The Mayer Institute Articles

A Tri-Corder for your Smart Phone?

PV Mayer — 27 Jan 2012 08:34:32 EST

New device will detect infections, cancer in minutesCBC News Posted: Jan 26, 2012 11:00 AM ET Last Updated: Jan 26, 2012 8:02 PM ETThis is the prototype of the new detection device developed by Dr. Shana Kelley at the University of Toronto. (CBC)Facebook48Twitter3Share51EmailExternal LinksKelley Laboratory(Note:CBC does not endorse and is not responsible for the content of external links.)

TMI Team Sends Patients on Road Trip to Revascularization

PV Mayer — 13 Jan 2012 09:34:02 EST

Joanna Frketich Sat Jan 14 2012 2 RecommendDiabetes patients head to Toronto or lose a limbDr Perry Mayer Dr. Perry Mayer treats patients with diabetic foot and wound issues in his Railway Street clinic. Many of his patients are on such a long wait list for surgery that they run the risk of loosing a limb. Mayer sends these patients to Toronto for surgery even though the surgery could be done here in Hamilton.Cathie Coward/The Hamilton SpectatorDiabetes patients in danger of losing limbs are being sent to Toronto for treatment because Hamiltons waits are too long.The Mayer Institute, which specializes in diabetes wound care, sends patients needing urgent treatment, within 30 days, to vascular surgeons at Sunnybrook Health Sciences Centre instead of waiting for diagnostics and surgery at Hamilton Health Sciences or St. Josephs Healthcare.In my world, I wait an inordinate amount of time, said the institutes medical director, Dr. Perry Mayer. Its a ridiculous situation in Hamilton. We have brilliant, gifted surgeons here, theyre second to none. But their hands are tied.Hamiltons lead vascular surgeon says the problem is that 90 per cent of patients referred to them are urgent, so it can be difficult to determine who gets the care first.A lot of us feel overwhelmed with the sheer volume of disease, said Dr. David Szalay, division head of vascular surgery at HHS, St. Josephs and McMaster University. The challenge can be to try to work through your list and make sure nobody dies of a ruptured aneurysm waiting for you, nobody has a stroke waiting and you can intervene on the leg quick enough to prevent limb loss.Szalay says the delays occur when patients are referred and waiting for their first appointment and again when surgeons order diagnostic tests. In contrast, Toronto has more vascular surgeons to share the load, so patients get their first appointment faster. The doctors at Sunnybrook also have access to their own angioplasty suite so they do the diagnostics themselves and immediately do the treatment.Their model is ideal but pretty unique, Szalay said of Sunnybrook.Angelo Maletta says he would have lost his foot if hed waited any longer for treatment. The 61-year-old Welland maintenance worker was told in August his right foot would have to be amputated because of a diabetic wound.His cousin knew someone whose leg was saved by Mayer and recommended the clinic on Railway Street. Many of Mayers patients tell the same story of finding the institute by chance from friends or family after being told theyd need an amputation.My cousin, who I hadnt seen in months, happened to be at my house the day they told me they wanted to amputate, said Maletta, who shudders to think what would have happened otherwise. It would have been terrible for me.Maletta saw Mayer at the end of August. Tests showed there was not enough blood flow in his foot, so he was referred to Sunnybrook in October and had surgery on Nov. 9.Everything was just boom, boom, boom, said Maletta, commenting on the speed of treatment.His foot is now healing well.Getting treatment fast is significant considering Wound Care Canada reports there is a small window of opportunity for therapies. More than 50 per cent of lower extremity amputations are due to non-healing foot ulcers and the long-term prognosis isnt good for amputees. The death rate is 39 per cent to 68 per cent over a five-year period.There is hope that waits will ease a bit in Hamilton as another vascular surgeon is being recruited � the equivalent of three fewer surgeons are practising in this area compared to seven years ago. A second vascular ultrasound opened last week to double diagnostic capacity, and other health professionals such as physician assistants are being added to the vascular team.But until then, Mayer says he will continue to send patients to Toronto: These people cant wait. The patients who dont get to me lose their limbs. They lose their limbs at an astonishing rate.jfrketich@thespec.com905-526-3349 | @Jfrketich

Part 1 on Infection by Frykberg

PV mayer — 03 Jan 2012 06:55:59 EST

The Challenges of Diabetic Foot Infections:Part 1 Ive had a particularly difficult (and frustrating) week caring for several patients with very severe diabetic foot infections. Ive been at this for about 35 years now, but it doesnt seem to be getting any easier. Perhaps the patients are just getting more complex and sicker or perhaps the pathogens are getting more virulent. Regardless, the infections just seem to be getting more difficult to control. While we have many more antimicrobial agents than we did years ago, antibiotics are only part of the solution to managing foot infections in the diabetic patient. We certainly need to have a very good understanding of the spectrum of coverage (and gaps in coverage) for a number of different agents. But the reality is, antibiotics alone can most often NOT be relied on to be the magic bullet for managing such complications. In fact, a good friend of mine who specializes in such matters is known to advocate that draino is the best (and perhaps the most important) agent for treating diabetic foot infections (DFI). Others can do a better job than I of discussing the multitude of antimicrobial therapies available for treating such infections (and perhaps it might be the subject of a future discussion). Hence, I will focus here on the non-pharmacologic principles of assessment and management that are critical to success in this regard. For the purposes of our discussion, we will concentrate primarily on limb threatening (moderate or severe) infections.The Physical ExamA systematic and thorough evaluation is absolutely essential to detect associated abnormalities that either directly lead to the infection or contribute to its severity. Medical history and evaluation is obviously important for antecedent injuries, comorbidities such as kidney disease, peripheral arterial disease, heart disease, diabetes control and medications, allergies, etc.A diabetic foot ulcer (DFU) is rarely caused by an infection but is perhaps the most frequent causal factor leading to diabetic foot infections. Sometimes it is just a blister or a burn (especially in the Summer heat of Arizona) or a puncture wound that breaks the skin envelope and opens the portal to infection. In the most severe presentations (necrotizing soft tissue infections) signs will include secondary blisters, bullae, or necrosis proximal to open wounds or gangrenous toes.Fig. 1. Necrotizing soft tissue infection- no gas on x-rays but note the severe cellulitis, edema, and necrotic dorsal skin. The portal of entry was in the webspace at the base of the second toe.Palpation of the foot might not only express purulence, but subcutaneous crepitance might be palpable as well. Ulcers of long duration or with bone exposure are at high risk for developing infections. Therefore, it is important to carefully examine such lesions - or to look for them when they might be between the toes. A sterile probe or even applicator stick can be used to examine the depths of any wounds to ascertain bone involvement or exposure or whether sinus tracts extend proximally along fascial planes or tendon sheaths. While this probe-to-bone test has been maligned as a good indicator for osteomyelitis, in hospitalized patients with severe infections, it actually has quite good predictive value for osteomyelitis. It is therefore a routine and essential part of my examination.While many, if not most, of hospitalized patients with DFIs have at least some degree of peripheral neuropathy and sensory loss, you must always look for underlying ischemia. I am quite impressed with the frequency of undetected peripheral arterial disease (PAD) that we first diagnose upon presentation with a rather severe DFI. Perhaps the frequency of neuroischemic wounds has risen over the years; certainly the number of foot infections in such patients has in my clinical practice. Hence, palpation of pulses (at least from the Popliteal to pedal arteries) is a key part of the examination as well. Too often, however, the foot is so swollen that pulses- even when present- are difficult to palpate. This is why I carry a Doppler ultrasound unit in my pocket. I will routinely ascertain the presence and quality of Doppler signals in the pedal vessels. While rarely finding triphasic signals in the affected feet, we will often find biphasic or monophasic signals in the dorsalis pedis and posterior tibial arteries. Monophasic signals portend peripheral arterial disease, although when intermetatarsal artery signals are present, there is less concern for critical ischemia. Nonetheless, we very liberally order Doppler Segmental Limb Pressures and ankle-brachial indices (ABI) or toe pressures for qualitative and quantitative evidence of peripheral perfusion. Pulse volume recordings (PVR) are also quite useful in this regard, especially in the presence of calcified arteries in this patient population. Vascular surgical consultation to assess the need for angiography and revascularization is necessary when significant abnormalities are found.Imaging X-rays, of course, must be taken to determine whether there are underlying foreign bodies, deformities (Charcot), or signs of osteomyelitis. Equally important, one must always look for the presence of subcutaneous gas. Necrotizing soft tissue infections, whether caused by anaerobes, gram negative bacilli, staphylococci, or Beta-hemolytic streptococci frequently demonstrate gas accumulations around and proximal to the original focus of infections. Accordingly, plain films of the leg must also be taken to ensure that the foot infection does not involve these fascial planes or tendon sheaths. There are obvious treatment implications emergent treatment implications- when gas is found in the soft tissues. But air is not gas in this sense of the word- sometimes air is found in the periwound area from walking on the foot. This is called emphysema and this is really not an emergency. When undrained abscesses or osteomyelitis are suspected, MRI or other advanced imaging can assist in making the diagnosis.Fig. 2. Note the soft tissue defect adjacent to the first MTP joint and the gas at the lateral ankle in this other patient. Laboratory StudiesLaboratory studies are, of course, critical in determining the patients response to the infection and help determine its severity. While complete blood count (CBC), differential, serum glucose, glycohemoglobin, and sedimentation rate are routine labs in this scenario, one must recognize that leukocytosis does not always accompany a moderate or severe infection in the diabetic patient. Hence, the clinician cannot be lulled into a false sense of comfort upon not finding an elevated white blood count (or elevated temperature for that matter). Suspicion and caution are the best attributes of the provider caring for such patients. Routine assessment of renal function is also necessary, following serum creatinine, blood urea nitrogen, and estimated glomerular filtration rate (eGFR). These values will obviously affect antimicrobial dosing as well as consideration for angiography and contrast for MRI studies.ClassificationOnce the patient assessment has been completed, classification of the infection will be helpful in guiding treatment. The Infectious Disease Society of America (IDSA) has put forth a DFI Classification scheme that has been almost universally adopted here and abroad. (See Table below) This scheme is an expansion of the former non-limb threatening/ limb threatening classification used several decades ago.The reader is referred to the references below for an in-depth review of the points discussed in this months ezine. Next month, in Part II, we will discuss treatment of the infected diabetic foot. As always, your comments are always appreciated and encouraged.###References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on eTalk.Best regards,Robert Frykberg, DPM, MPHPRESENT Editor, Diabetic Limb SalvageREFERENCESEneroth M, Apelqvist J, Stenstrom A. Clinical characteristics and outcome in 223 diabetic patients with deep foot infections. Foot Ankle Int. Nov 1997;18(11):716-722.Frykberg RG. An evidence-based approach to diabetic foot infections. Am J Surg. Nov 28 2003;186(5A):44S-54S; discussion 61S-64S.Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-Oct 2006;45(5 Suppl):S1-66.Lipsky BA, Berendt AR, Deery HG, et al. Diagnosis and treatment of diabetic foot infections.Clin Infect Dis. Oct 1 2004;39(7):885-910.Caputo GM, Cavanagh PR, Ulbrecht JS, Gibbons GW, Karchmer AW. Assessment and management of foot disease in patients with diabetes. N Engl J Med. Sep 29 1994;331(13):854-860.Grayson ML, Balaugh K, Levin E, Karchmer AW. Probing to bone in infected pedal ulcers. A clinical sign of underlying osteomyelitis in diabetic patients. J Am Med Assoc.1995;273(9):721-723.Lavery LA, Armstrong DG, Wunderlich RP, Mohler MJ, Wendel CS, Lipsky BA. Risk factors for foot infections in individuals with diabetes. Diabetes Care. Jun 2006;29(6):1288-1293.

Part 2 on DFU Infection by Frykberg

PV mayer — 03 Jan 2012 06:54:16 EST

The Challenges of Diabetic Foot Infections:(Part 2) In the last issue of FootNotes, we focused on what I consider to be the essential components in the assessment of patients presenting with diabetic foot infections. Although I concentrated on severe or limb threatening foot infections, the principles remain the same for even mild or moderate infections: always be suspicious, always look for ischemia, and always obtain appropriate laboratory tests and imaging procedures as essential parts of your evaluation. Also important, please recognize that just having a wound does not imply that it is infected; most, if not all, wounds are contaminated. Infection is a clinical diagnosis based on those classical signs we are all familiar with: rubor, tumor, dolor, and calor. Nonetheless, diabetes (like syphilis) has become the great masquerader in that typical signs and symptoms are masked especially in the presence of neuropathy. Hence, my exhortation that one must always be suspicious in such patients who often do not respond to treatment the way one would expect them to under normal circumstances (i.e. persistent fever after several days of ostensibly appropriate therapy).So now let us focus on the management of established diabetic foot infections that have been appropriately evaluated. Our focus will always be aimed at limb salvage, a much harder task in many cases than primary leg amputation.Management of Diabetic Foot InfectionsAntibiotics are only part of the management strategies for these complicated patients, although a significant component, of course. In most cases, however, antimicrobial therapy becomes adjunctive to non-pharmacologic (surgical) therapy. An old adage from my years of training in Boston stipulates that diabetic patients cannot tolerate undrained infection (I believe this comes from an old friend and surgeon, Gary Gibbons). This is a good point to remember, since it is painfully driven home whenever it is forgotten. As I mentioned earlier, those patients not responding to antimicrobial therapy alone likely are failing due to an undrained abscess or retained necrotic tissue. This is a very common scenario and one that is seen especially frequently in those patients with necrotizing soft tissue infections (necrotizing fasciitis, necrotizing cellulitis, clostridial myonecrosis, etc.). These patients typically require several trips to the operating room before their infection is controlled- short of doing a primary major amputation. Last month, I presented a case of necrotizing soft tissue infection. (Figure 1 ) As in this case, such patients do not always present with gas in the soft tissues that would be too easy. Gas easily identifies those individuals requiring an urgent trip to the operating room few would miss this clinical clue. Nonetheless, many individuals present with severe cellulitis and some soft tissue necrosis even in the absence of purulent drainageFig. 1. Necrotizing soft tissue infection- no gas on x-rays but note the severe cellulitis, edema, and necrotic dorsal skin. The portal of entry was in the webspace at the base of the second toe. No ischemia was present.They may or may not be sick (IDSA Grade 4 or 3), but the severity of their infection is signified by recalcitrant hyperglycemia, leukocytosis, and failure to resolve cellulitis with broad spectrum antimicrobial therapy. These important clinical clues should indicate that, very likely, surgical debridement or partial foot amputation is necessary. Several procedures are often required prior to eventual control of infection and definitive closure. (Figures 2-4)Fig. 2. Same patient after initial extensive debridement and toe amputations. Although infection somewhat improved, further necrosis and persistent cellulitis required further debridement.Fig. 3. After further debridement and toe amputations, the infection came under control. A large soft tissue and osseous defect remained with residual necrosis at the midfoot, placing the limb at risk.Fig. 4. Definitive closure was obtained with a Chopart amputation.Equally important is the necessity for detecting and treating peripheral ischemia (PAD) when present. Many patients with pre-existing PAD have a foot infection as their first presenting sign of ischemia. In the presence of neuropathy, critical limb ischemia is often silent in that the usual symptoms of claudication or rest pain are absent. Therefore, in all patients presenting with acute foot infection it is prudent to look for underlying PAD and request appropriate vascular studies and consultations. That being said, ischemia does not preclude appropriate surgical management for the acute infection. It is still essential to drain abscesses or to perform emergent local amputations to control infection. Revascularization should be performed after immediate control of infection. A final, definitive procedure such as a closed amputation or skin graft should follow the revascularization and restoration of perfusion to the foot.We have previously discussed the management of osteomyelitis in Diabetic Footnotes Issue 18 - Osteomyelitis � Now What?, but it is worth mentioning again in the overall context of managing diabetic foot infections. I am of the (biased) opinion that in the diabetic foot, osteomyelitis is best managed surgically in most instances. While this is a matter of debate around the Globe, surgical debridement or bone resection (and sometimes local amputation) with adjunctive systemic antimicrobial therapy seems to more predictably affect a cure than treatment with just antibiotics. This is the course of treatment followed by most US surgeons until prospective studies can definitively identify those sites or patients best suited to medical therapy alone. Nonetheless, osteomyelitis very rarely, if ever, presents as an acute problem it usually comes associated with an acute soft tissue infection.Once the acute infection has been managed, the bone infection can be definitively treated as appropriate for the circumstances. For instance, in a patient with an infected plantar ulcer of a metatarsal head without gangrene, a joint resection with a 4 to 6 week course of culture-directed oral antibiotics will most often result in a cure.I have not specifically addressed antimicrobial therapy thus far, because I think that we need to place a good deal of emphasis on the surgical management of limb threatening infections. Nonetheless, in our next issue, we will discuss my approach to antimicrobial management of diabetic foot infections from a clinicians viewpoint. I have been in the trenches for many years in this regard and have made many mistakes. Hopefully, Ive learned from them and can offer some guidance to you as well. Until next time�###References are provided below that can expand upon many of the points made above. We welcome your opinions, concerns, and suggestions. If you have an interesting case or a troubling circumstance that you would like to share with fellow PRESENT Diabetes members, please feel free to comment on eTalk.Best regards,Robert Frykberg, DPM, MPHPRESENT Editor, Diabetic Limb SalvageREFERENCESEneroth M, Apelqvist J, Stenstrom A. Clinical characteristics and outcome in 223 diabetic patients with deep foot infections. Foot Ankle Int. Nov 1997;18(11):716-722.Frykberg RG. An evidence-based approach to diabetic foot infections. Am J Surg.Nov 28 2003;186(5A):44S-54S; discussion 61S-64S.Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. Sep-Oct 2006;45(5 Suppl):S1-66.Lipsky BA, Berendt AR, Deery HG, et al. Diagnosis and treatment of diabetic foot infections. Clin Infect Dis. Oct 1 2004;39(7):885-910.Javier Arag�n-S�nchez, Yurena Quintana-Marrero, Jose L. L�zaro-Mart�nez, et al: Necrotizing Soft-Tissue Infections in the Feet of Patients With Diabetes: Outcome of Surgical Treatment and Factors Associated With Limb Loss and Mortality. INT J LOW EXTREM WOUNDS 2009; 8; 141Javier Arag�n-S�nchez: Seminar Review: A Review of the Basis of Surgical Treatment of Diabetic Foot Infections International Journal of Lower Extremity Wounds 2011 10: 33

The Cost of Diabetes Keeps Rising

PV mayer — 03 Jan 2012 06:46:19 EST

Cost of Diabetes Will Be $3.35 Trillion by 2020The United States of Diabetes: New report shows half the country could have diabetes or prediabetes at a cost of $3.35 trillion by 2020.More than 50 percent of Americans could have diabetes or prediabetes by 2020 at a cost of $3.35 trillion over the next decade if current trends continue, according to new analysis by UnitedHealth Group's Center for Health Reform & Modernization, but there are also practical solutions for slowing the trend. See this week's Tool for Your Practice.New estimates show diabetes and prediabetes will account for an estimated 10 percent of total health care spending by the end of the decade at an annual cost of almost $500 billion -- up from an estimated $194 billion this year.The report, The United States of Diabetes: Challenges and Opportunities in the Decade Ahead,produced for November's National Diabetes Awareness month, offers practical solutions that could improve health and life expectancy, while also saving up to $250 billion over the next 10 years, if programs to prevent and control diabetes are adopted broadly and scaled nationally. This figure includes $144 billion in potential savings to the federal government in Medicare, Medicaid and other public programs.Key solution steps include lifestyle interventions to combat obesity and prevent prediabetes from becoming diabetes and medication control programs and lifestyle intervention strategies to help improve diabetes control.Our new research shows there is a diabetes time bomb ticking in America, but fortunately there are practical steps that can be taken now to defuse it, said Simon Stevens, executive vice president, UnitedHealth Group, and chairman of the UnitedHealth Center for Health Reform & Modernization. What is now needed is concerted, national, multi-stakeholder action. Making a major impact on the prediabetes and diabetes epidemic will require health plans to engage consumers in new ways, while working to scale nationally some of the most promising preventive care models. Done right, the human and economic benefits for the nation could be substantial.The annual health care costs in 2009 for a person with diagnosed diabetes averaged approximately $11,700 compared to an average of $4,400 for the remainder of the population, according to new data drawn from 10 million UnitedHealthcare members. The average cost climbs to $20,700 for a person with complications related to diabetes. The report also provides estimates on the prevalence and costs of diabetes based on health insurance status and payer, and evaluates the impact on worker productivity and costs to employers.Diabetes currently affects about 27 million Americans and is one of the fastest-growing diseases in the nation. Another 67 million Americans are estimated to have prediabetes. There are often no symptoms, and many people do not even know they have the disease. In fact, more than 60 million Americans do not know that they have prediabetes. Experts predict that one out of three children born in the year 2000 will develop diabetes in their lifetimes, putting them at grave risk for heart and kidney disease, nerve damage, blindness and limb amputation.Estimates in the report were calculated using the same model as the widely-cited 2007 study on the national cost burden of diabetes commissioned by the American Diabetes Association (ADA).The report also focuses on obesity and its relationship to diabetes. Being overweight or obese is one of the primary risk factors for diabetes, and with more than two-thirds of American adults and 17 percent of children overweight or obese, the risk is clearly rising. In fact, over half of adults in the U.S. who are overweight or obese have either prediabetes or diabetes, and studies have shown that gaining just 11-16 pounds doubles the risk of type 2 diabetes and gaining 17-24 pounds nearly triples the risk.Because diabetes follows a progressive course, often starting with obesity and then moving to prediabetes, there are multiple opportunities to intervene early and prevent this devastating disease before it's too late, said Deneen Vojta, M.D., senior vice president of the UnitedHealth Center for Health Reform & Modernization, who helped develop UnitedHealth Group's Diabetes Prevention and Control Alliance.

Tackling Diabetic Foot Disease in China

PV Mayer — 20 Oct 2011 10:02:54 EST

Diabetic foot care in mainland ChinaDiabetic foot ulcers, Service delivery | Zhangrong XuDiabetes is a major non-communicable disease worldwide. There are now some 40 million people with diabetes and a similar number with impaired fasting glucose or impaired glucose tolerance in mainland China alone (China News, 2008). Among those with diabetes, diabetic foot disease is becoming a serious health burden, impacting negatively both on peoples quality of life and on healthcare budgets.The First and Second Diabetic Foot Groups of the Chinese Diabetes Society were founded in 1996 and 2002, respectively. The groups aimed to establish a campaign to improve diabetic foot care in China. This included the participation of the Second Diabetic Foot Group in the International Consensus on the Diabetic Foot, which was published by the International Diabetes Federation (International Working Group on the Diabetic Foot, 2003).The Third Diabetic Foot Group of the Chinese Diabetes Society was founded in October 2008 and is currently active. This group aims to recruit new members from fields not specifically diabetes related, such as orthopaedic and vascular surgery, but whose contribution to diabetic foot care is essential.Over the past 5 years, various national meetings on diabetic foot disease and its management and prevention have been held at both local and national levels in China. A number of international experts in the field of diabetic foot care have been invited to China for lectures and clinical visits. The International Forum on Diabetic Foot and Related Diseases was held in Beijing in 2005 and 2006, in Kunming in 2007, and in Chengdu in 2008. Some 400-500 delegates attended each of these 3-day meetings. Workshops where held, during which approximately 100 participants were divided into groups to learn how to conduct basic examinations of the diabetic foot and investigations for peripheral vascular disease. A range of topics were covered, including taking an ankle-brachial pressure index and ulcer dressing choice. The workshops were mostly attended by physicians and nurses from teaching hospitals. Many attendees asked the Diabetic Foot Group to hold similar workshops in the future. To date, more than 1500 healthcare professionals have participated in diabetic foot care training provided by the group.In August of this year, the 5th International Forum on Diabetic Foot and Related Diseases was held simultaneously with the 6th Asia-Pacific Diabetic Limb Problems Meeting in Beijing. More than 500 participants from 16 countries took part. Speakers included Professors Robert Frykberg, Andrew Boulton, David Amstrong, Bejamin Lipsky and Dennis Yue, as well as Marg McGill, Senior Vice-President of the International Diabetes Federation.There are now more diabetic foot clinics in China than ever before, with seven new centres established in the past 5 years. However, relative to the size of the population with diabetes, there remains too few diabetic foot centres. The clinic at which I work has treated more than 350 people with diabetic foot problems over 5 years. We have been able to achieve a reduction in the amputation rate from 11.5% 5 years ago to 7.2% (mostly minor amputations) today.Some newer techniques for the management of diabetic foot disease have been used in Chinese clinics. These include vascular intervention (stents, Figure 1), and the transplantation of autologous peripheral blood stem-cells for the treatment of peripheral vascular disease. Autologous platelet-rich gels and negative pressure therapy have also been used for the treatment of hard-to-heal ulcers, with some diabetic foot centres achieving positive results. Some Chinese physicians treat foot problems with a combination of Western medicine and traditional Chinese medicine.Figure 1. Ischaemic ulcer (a) upon admission to hospital and (b) shortly after. Reperfusion was undertaken, the vascular supply is shown (c) before and (d) after intervention. The ulcer (e) 2 weeks after the intervention, and (f) 2 months after the intervention. In an effort to increase the amount of literature available to healthcare professionals with an interest in the diabetic foot working in China, the Diabetic Foot Group has undertaken a number of initiatives. The International Consensus on the Diabetic Foot (International Working Group on the Diabetic Foot, 2003) has been translated into Chinese and is now in its second print run, with 6000 copies distributed to-date. The group has worked with experts from a range of fields to produce books that introduced topics on the care of the diabetic foot. The output of literature from China has likewise increased. The number of scientific articles published by practitioners working in diabetic foot care in China has risen dramatically, from 6 in 1996 to 360 in 2006.In 2004, the Diabetic Foot Group organised research involving 14 teaching hospitals located in cities around China. A range of topics were investigated, including the classification and pathogenesis of diabetic foot disease and peripheral arterial disease, and the cost of diabetic foot disease to hospitals. People (n=634) with diabetes and foot problems or peripheral arterial disease admitted from 1 January to 31 December 2004 were included in this research. Neuropathy was present in 68.0% of participants, hypertension in 57.4%, peripheral arterial disease in 28.7%, coronary heart disease in 28.5%, cerebral vascular disease in 24.3%, and 38.8% were smokers. Foot ulcers were, in the majority (82.2%) of cases, at Wagner stage 1 or 2. In 42.7% of cases, more than one ulcer was present, and 67.9% of ulcers were complicated by infection. Ulcers were commonly neuroischemic. The average direct medical cost to the hospital attributable to diabetic foot disease or peripheral arterial disease in people with diabetes was �RMB 14906/person ($US 1850/person). Our results were presented at the 5th International Symposium on the Diabetic Foot held in The Netherlands (Xu, 2007).Diabetic foot disease is becoming a serious health and economic burden in China and around the world. The First, Second and Third Diabetic Foot Groups of the Chinese Diabetes Society have looked to provide healthcare professionals working in China with more information on, and clinical skills in, the management of diabetic foot disease. Practitioners in China look forward to increasing national and international cooperation between those with an interest in the care of the diabetic foot, through knowledge-sharing and participation in research. REFERENCESChina News (2008) [Rapidly increasing prevalence of diabetes in China.] (In Chinese) Available from: http://tinyurl.com/yfnwsfz (accessed 26.10.09) International Working Group on the Diabetic Foot (2003) International Consensus on the Diabetic Foot and Practical Guidelines on the Management and the Prevention of the Diabetic Foot. International Diabetes Federation, AmsterdamXu Z (2007) The diabetic foot in China. 5th International Symposium on the Diabetic Foot, 9-12 May 2007, Noordwijkerhout, The Netherlands

Theragnostics on Steriods

PV Mayer — 20 Oct 2011 10:01:19 EST

Next Up for Artificial Intelligence: Real Biologyby BRIAN KLEIN on Oct 14, 2011 � 5:46 pmFirst, artificial intelligence trumped expert chess players at their own game. Then came Watson, a computer system that famously beat Jeopardy. champions Brad Rutter and Ken Jennings. Now, researchers are putting artificial intelligence to work to automate biological research�-specifically the reverse engineering of metabolic networks from experimental data.A team of scientists from Vanderbilt University, Cornell University, and CFD Research Corp. have shown that a computer can take raw experimental numbers from a biological data and derive equations from it that describe how the system functions. The modelling used in the research is said to be one of the most complex scientific modeling problems that artificial intelligence has solved completely from scratch.Check out the announcement from Vanderbilt University:The brains of the system, which [Vanderbilt professor John P. Wikswo] has christened the Automated Biology Explorer (ABE), is a unique piece of software called Eureqa developed at Cornell and released in 2009. [Michael Schmidt and Hod Lipson at the Creative Machines Lab at Cornell University] originally created Eureqa to design robots without going through the normal trial and error stage that is both slow and expensive. After it succeeded, they realized it could also be applied to solving science problems.One of Eureqas initial achievements was identifying the basic laws of motion by analyzing the motion of a double pendulum. What took Sir Isaac Newton years to discover, Eureqa did in a few hours when running on a personal computer.In 2006, Wikswo heard Lipson lecture about his research. I had a �eureka moment of my own when I realized the system Hod had developed could be used to solve biological problems and even control them, Wikswo said. So he started talking to Lipson immediately after the lecture and they began a collaboration to adapt Eureqa to analyze biological problems.Biology is the area where the gap between theory and data is growing the most rapidly, said Lipson. So it is the area in greatest need of automation.Wikswo believes that artificial intelligence could potentially be harnessed to generate and analyze biological data to such a degree that it could predict the behavior of biological systems under a variety of conditions.[Wikswo also] maintains that this approach will give scientists the ability to control biological systems even if [the researchers] cant completely explain how they work, and this capability can provide the basis for the development of significantly improved drugs and other therapies.According to Cornell professor Hod Lipson, the researchers might need to create another program to translate the meaning of the equations that the Eureqa program comes up with.This this video from a couple of years ago explains how the Eureqa software derived the fundamental equations of motion from observations of a double pendulum.Top image: The microformulator pictured enables the biological experiments to be performed without human intervention. Image credit: Wikswo Lab.Abstract in Physical Biology: Automated refinement and inference of analytical models for metabolic networksPress release: Robot biologist solves complex problem from scratch

Amputation Rates Vary Widely Across US

PV Mayer — 30 Sep 2011 02:48:45 EST

Location, Location, Location: Geographic Clustering of Lower-Extremity Amputation Among Medicare Beneficiaries With DiabetesDavid J. Margolis, MD, PHD⇓, Ole Hoffstad, MA, Jeffrey Nafash, BA,Charles E. Leonard, PHARMD, MSCE, Cristin P. Freeman, MPH,Sean Hennessy, PHARMD, PHD and Douglas J. Wiebe, PHD+Author AffiliationsDepartment of Biostatistics and Epidemiology and the Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PennsylvaniaCorresponding author: David J. Margolis, margo@mail.med.upenn.edu.AbstractOBJECTIVE Lower-extremity amputation (LEA) is common among persons with diabetes. The goal of this study was to identify geographic variation and the influence of location on the incidence of LEA among U.S. Medicare beneficiaries with diabetes.RESEARCH DESIGN AND METHODS We conducted a cohort study of beneficiaries of Medicare. The geographic unit of analysis was hospital referral regions (HRRs). Tests of spatial autocorrelation and geographically weighted regression were used to evaluate the incidence of LEA by HRRs as a function of geographic location in the U.S. Evaluated covariates covered sociodemographic factors, risk factors for LEA, diabetes severity, provider access, and cost of care.RESULTS Among persons with diabetes, the annual incidence per 1,000 of LEA was 5.0 in 2006, 4.6 in 2007, and 4.5 in 2008 and varied by the HRR. The incidence of LEA was highly concentrated in neighboring HRRs. High rates of LEA clustered in contiguous portions of Texas, Oklahoma, Louisiana, Arkansas, and Mississippi. Accounting for geographic location greatly improved our ability to understand the variability in LEA. Additionally, covariates associated with LEA per HRR included socioeconomic status, prevalence of African Americans, age, diabetes, and mortality rate associated with having a foot ulcer.CONCLUSIONS There is profound region-correlated variation in the rate of LEA among Medicare beneficiaries with diabetes. In other words, location matters and whereas the likelihood of an amputation varies dramatically across the U.S. overall, neighboring locations have unexpectedly similar amputation rates, some being uniformly high and others uniformly low.Received April 29, 2011.Accepted July 28, 2011.

Early Insulin Use in the Progression of Diabetes by the Master, Dr Aaron Vinik

PV Mayer — 29 Sep 2011 04:23:30 EST

Dr. Aaron I. Vinik on Early Insulin Use in the Progression of DiabetesOne of the leading diabetes researchers in the world, Dr. Aaron I. Vinik, Director of Research and Neuroendocrine Unit, EVMS Strelitz Diabetes Research Center, shares his views on early insulin initiation.The natural history of type 2 Diabetes (T2DM) is a progressive worsening of glycemic control as a consequence of progressive beta cell failure so that ultimately all patients with T2DM are equivalent to patients with type 1 DM and are insulin deficient. In addition the clock starts ticking for macrovascular complications such as heart attacks, strokes and peripheral vascular diseases before the advent of fasting or postprandial hyperglycemia indicating that there are, in addition to hyperglycemia, a host of risk factors conducive to macrovascular disease. In contrast, the glycemia milieu is the single most important determinant of microvascular complications Major studies in T2DM have indubitably shown a reduction of microvascular complications by good glycemic control and the effect persists despite failure to maintain A1c's near normal. This is in stark contrast with the recent attempts to show that intensive glycemic control in the ACCORD, ADVANCE and VADT studies reduce macrovascular events: somewhat disconcerting was the finding in the ACCORD study of an increase in sudden death by 22% in the intensively treated group. Thus, the window of opportunity to aggressively treat T2DM is early and patients can enjoy a 'legacy effect' or what has been reported as metabolic memory. Why then did we not see this benefit in the three studies above and what have we learned? The lessons were invaluable and suggest that there can be a bad metabolic memory or legacy effect in certain situations:1. If the diabetes has been there for > 12-15 years;2. Older people and African Americans;3. Significant impairment of renal function;4. The presence of coronary calcification;5. The history of peripheral neuropathy and the findings of autonomic neuropathy.So the window of opportunity has to be early in the absence of kidney, somatic and autonomic dysfunction, established cardiovascular disease and there are gender and ethnic group sensitivities. Perhaps the only protective factor appears to be obesity but that is almost contrary to everything we are trying to achieve in T2DM.So armed with this information, why is it that we have developed a treat-for-failure approach trying several medications, diet and exercise and only when we have failed to reach goal do we make adjustments? The median delay of adjusting a sulfonylurea is 24 months and metformin is 36 months. Titration is a tardy task and treating for failure is doomed to failure. A fundamental change in physicians' management of T2DM is required and the traditional treatment algorithm should emphasize treatment for success not failure.Traditional oral hypoglycemic agents such as sulfonylurea, metformin, the glitazones and the Incretins and Gliptins are able to lower A1c's about 0.5 to 2.0 %. Combinations of these agents can under optimum conditions achieve an A1c reduction of 3%. Thus in people close to goal of 6.5% (AACE) or 7.0% (ADA) then exercise, diet and a single agent are appropriate. If the A1c is between 7.5% and 9.0%, combinations of oral agents are an appropriate first choice. When A1c is > 9.0 we need the unlimited capacity of insulin to achieve goal. This can be accomplished in a number of ways which include addition to the oral regimen, use of a single long acting insulin analog, use of combinations of different forms of insulin and finally a basal long acting insulin together with a short acting bolus based upon the prevailing blood glucose and the anticipated carbohydrate intake. Data from the UKPDS indicate that after insulin is introduced either alone or in combination with oral therapy, the long term outcome is improved glycemic control. There is however a clinical inertia amongst generalists and even endocrinologists to make these change.The barriers to initiation of insulin therapy are legion. Physicians have a fear of hypoglycemia and imagine there are adverse health consequences of the insulin itself. They have misconceptions of the regimens as being too complex and that it should be the therapy of last resort or limited efficacy. They are indeed major contributors to the fear patients have of the needle. This is a paradox when the needle per se is more benevolent than, for example, a finger stick. Patient-related behaviors are fear of hypoglycemia, adverse health outcomes, medication errors, needles and pain, weight gain and the complicated regimens and scheduling of injections. Unfortunately patients have been brainwashed into thinking that use of insulin is a personal failure, their disease is too advanced, it is the therapy of last resort and it greatly increases cost. Our own studies comparing insulin with oral agents have shown that insulin is associated with improved quality of life, less fatigue, increase in energy and enhanced state of emotion. Patient education along with the use of insulin formulations that reduce risk of hypoglycemia and weight gain, simplified treatment regimens and easy to use insulin delivery systems, should help to reduce the barriers to early aggressive insulin use when the window of opportunity presents itself and clinicians need to overcome inertia and not allow the window to close upon them. Every day here at the EVMS Strelitz Diabetes Center we see patients who are grateful for the restoration of their quality of life as well as the anticipated reduction of the burden of diabetes complications.Dr. Aaron I. Vinik has written five books, published more than 250 papers in medical journals, and is recognized as a pioneer and scholar. Dr. Vinik has received research funding for his studies from the National Institutes of Health, the National Cancer Institute, the Kroc Foundation and the American Diabetes Association. He is a leader in research on the diagnosis and treatment of diabetic neuropathy with a particular expertise in the area of autonomic diabetic neuropathy, a complex and challenging condition. Dr. Vinik has also been a leader in research on new approaches to generate islet cell tissue from pancreatic duct tissue which may one day lead to a true cure for diabetes.For more information on Dr. Vinik and his groundbreaking work at the Strelitz Diabetes Center, just follow this link, Eastern Virginia Medical School Strelitz Diabetes Center.

Primer in Wound Preparation by Rogers

PV Mayer — 26 Sep 2011 11:08:21 EST

Current Concepts In Wound Bed PreparationVolume 24 - Issue 8 - August 2011 3054 reads 0 commentsAuthor(s): Lee C. Rogers, DPMProper preparation of the wound bed is essential to priming the wound for effective healing. Accordingly, this author discusses key principles from the literature and shares insights from his clinical experience in employing debridement and adjunctive modalities to help facilitate better wound healing and eventual wound closure.Wound bed preparation is a term that describes making the wound ready for closure by advanced means. If the wound is not properly prepared, even the most expensive products or devices are unlikely to produce a positive outcome. One does not usually perform wound bed preparation in a single visit. There is more of a process to prepare the wound to be closed. In addition to the wound itself, one must ensure the patient is prepared for wound closure. Podiatric physicians must manage infection, ensure adequate vascularity and remove external pressure from the wound.1 One can confirm the patients vascular status via noninvasive testing since pedal pulses alone are not a good indicator of sufficient perfusion. If there is vascular impairment, podiatrists should consider an appropriate referral for an intervention to improve circulation. In regard to infection, patients with diabetes do not often mount systemic responses to infection. Therefore, clinicians must rely upon local signs. Is there erythema, purulent drainage or odor present? As infection is purely a clinical diagnosis, a culture cannot determine if the wound is infected. Cultures can only help to discern which bacteria are pathogens in that infection. Uninfected wounds should not be cultured. One can mitigate external pressure either by surgical intervention or by using devices such as a total contact cast or removable cast walker.2 Completing the above process and creating a good wound healing environment is considered the standard of practice in most communities. One monitors the wound over four weeks. If the wound area does not reduce by at least 50 percent in that time period, the wound is unlikely to heal in 12 weeks and one should employ advanced therapies.3 There are many advanced therapies, ranging from skin grafts and flaps to bioengineered tissues, but they all require the wound to be adequately prepared.A Closer Look At Key Factors That Can Affect Wound HealingWound bed preparation consists of far more than just a debridement and, in some cases, may take weeks to accomplish. The goal is to optimize the wound in order to promote healing with advanced means and remove the barriers to healing. Let us first consider the inherent factors that are detrimental to wound healing like bacteria, senescent cells and hyperkeratotic tissue. Bacteria. A wound is a break in the dermal envelope. It is usually contaminated by bacteria and may even have a biofilm present. Just because a wound is colonized does not mean that it is infected. If the wound becomes critically colonized with bacteria, an infection may develop. Researchers suggest that bacterial loads between 105 and 106 per gram of tissue in the wound bed may cause infection.4 However, more virulent organisms may cause infection at lower concentrations. Biofilm itself is detrimental to wound healing and will hinder the process, but infection causes tissue destruction. Biofilm is difficult to treat. At this time, only thorough debridement has proven to be a definitive treatment. Senescent cells. Cellular dysfunction is common in diabetic foot ulcers and other chronic ulcers. Somatic cells can only divide 50 times before their DNA telomeres have shortened and they can no longer replicate full copies of the DNA. At that point, there should be apoptosis or programmed cell death. In some diabetic wound healing models, researchers have shown that the apoptotic mechanism is impaired. They note that these old (senescent) cells continue to live in the wound but do not replicate or produce growth factors.5 The senescent cells impair the ability of the wound to heal. Hyperkeratotic tissue. This hardened tissue forms along the wound periphery and its formation is accelerated by pressure, either direct forces or shearing forces. Bearing weight on the hardened tissue causes subdermal tissue trauma and hemorrhage. Hyperkeratotic tissue acts as a barrier to epithelialization. This tissue can also undermine and collect fluid and debris, thus increasing the risk for infection.Using Debridement And Adjunctive Modalities To Prepare The Wound BedThe main goal of preparing the wound bed is to provide a healing surface, which would accept a graft. While wound bed preparation involves debridement, this is more than just debridement. It also includes consideration of the aforementioned factors such as bacteria, cell senescence and hyperkeratotic tissue. Debridement removes devitalized or contaminated material from within or surrounding the wound. Selective debridement stimulates the repair process. There are various methods of debridement including surgical (scalpel), hydrosurgical (Versajet, Smith and Nephew), biosurgical (maggots), enzymatic or mechanical (wet to dry dressings).6 I have heard the axiom that debridement converts a chronic wound into an acute wound. However, acute and chronic are specifically terms that describe time. One cannot take a chronic wound that has been open for four months and convert it into an acute wound present for one day. However, I believe debridement can put an acute injury into a chronic wound, which may provide growth factors and speed healing. For the purposes of wound bed preparation, surgical or hydrosurgical debridement is preferred. It can occur at the same time as grafting or precede grafting by up to a week. Use a scalpel to remove the wound margins, saucerizing the tissue, and then use a curette or hydroscalpel to debride the wound bed. The goal is to obtain a bleeding granular wound. If you are preparing a wound in the operating room for grafting, ensure that bleeding is under control prior to applying the graft in order to avoid a hematoma. Hematoma between the wound bed and the graft is a leading cause of graft failure. One should avoid electric cautery, if possible, and employ pressure, epinephrine or thrombin if needed If the wound is not completely granular, one should consider using either platelet-derived growth factor (PDGF, Regranex, Healthpoint Biotherapeutics) or negative pressure wound therapy (NPWT, VAC therapy, KCI) to make the wound granular and level with the surrounding tissue. The VAC therapy works well in combination with debridement to prepare the wound for grafting. VAC therapy can also assist in managing wound exudate. If one uses VAC therapy in the OR setting, ensure that bleeding is under control before applying NPWT. Armstrong and Lavery studied 162 patients as part of a 16-week randomized clinical trial.7 As part of the study, 77 patients received NPWT while 85 received standard moist wound care. They found that VAC therapy had a faster rate of developing granulation tissue in comparison to standard moist wound therapy. When choosing a biomaterial, foam is more effective than gauze at producing granulation tissue. Foam also compresses and contracts better than gauze, enhancing the wounds ability to contract. Employing a silver impregnated foam can help manage bioburden. When performing wound bed preparation a week prior to applying bioengineered tissue, one should perform an adequate debridement, saucerize the margins and promote a good wound healing environment with regular dressing changes until applying the tissue. The first photo on page 1 shows two wounds on the lateral surface of a foot that are fibrotic but uninfected. We performed debridement with a scalpel and curette, which uncovered a healthy bleeding base (see the second photo on page 1). The use of bioengineered tissue prepared the wound for grafting. This preparation occurred in a single stage. One can apply a silver dressing to the wound to manage bacterial load and prevent infection until the application of bioengineered tissue. Often, the wound requires a maintenance debridement at the time of grafting and during subsequent applications. Cardinal and colleagues retrospectively analyzed the results from two controlled, prospective, randomized trials of topical wound treatments on 366 venous leg ulcers and 310 diabetic foot ulcers over 12 weeks.8 The study results suggest that frequent debridement of diabetic foot and venous leg ulcers may increase wound healing rates. Maintenance debridements usually involve removing any obvious debris, fibrosis or hyperkeratotic margins. In some cases, the purpose of bioengineered tissue application might be to aid wound bed preparation because the cellular therapy provides the wound with multiple growth factors.Case Study: When There Is An Ankle Wound With Exposed TendonA 71-year-old male with diabetes presents to the clinic with a small, painful, undermining wound on the anterior ankle with an exposed extensor digitorum longus tendon. The wound was caused by direct trauma from a water sprinkler head. The tendon was visibly moving in the wound when the patient dorsiflexed and plantarflexed the ankle. This is problematic because bacteria has access to the tendon and can spread to adjacent compartments. The moving tendon also prevents granulation tissue from adhering. The patient went to the operating room for a wide debridement and I removed all undermining tissue. The patient was admitted to the hospital We started the patient on a VAC Ulta, a new product by KCI that instills a fluid into the wound. In this case, I infused one-quarter strength Dakins solution for the anti-infective and anti-inflammatory properties. With the VAC Ulta, one can tightly control the infusion/suction rate. I set this to instill 50 mL of Dakins solution, hold for five minutes, then resume suction and repeat the process every two hours. After three days, the wound appeared to improve but the tendon was still exposed. The patient went back to the OR, where we performed debridement with a Versajet. I placed Integra (Integra Life Sciences) on the wound and used traditional VAC therapy with the Granufoam Bridge Dressing as a bolster. The patient wore a total contact cast (TCC-EZ, MedEfficiency) to keep the tendon from moving under the graft. I changed the TCC-EZ and VAC therapy twice per week. After two weeks of treatment, the wound became granular and the tendon was covered. The aforementioned process describes wound bed preparation. I debrided the margins with a scalpel and performed light debridement of the wound bed with a Versajet. A split thickness skin graft was harvested from the anterolateral ipsilateral thigh at a thickness of 0.020 inches. I meshed this at 1:1.5 ratio, placed it on the wound and stapled it in place. I used a Mepitel silicone dressing (Molnlycke) as an interface. I placed VAC therapy on the graft as a bolster dressing and set this to -125 mmHg continuous pressure for five days. After VAC therapy removal, I covered the wound with Mepilex Ag (Molnlycke) at that point. The graft interstices healed in about 10 days. I covered the donor site with a Mepilex Border (Molnlycke) and changed it as needed. The wound healed uneventfully.Final WordsProper preparation of the wound bed is vital to graft or tissue success. Wound bed preparation is much more than just a debridement and takes into account factors that impede wound healing. By creating a recipient wound bed that is well vascularized, free from infection and granular with even sloping margins, we can increase the chance of graft take and facilitate more reliable wound healing. Dr. Rogers is the Associate Director of the Amputation Prevention Center at Valley Presbyterian Hospital in Los Angeles1. Rogers LC, Bevilacqua NJ. Organized programs to reduce lower-extremity amputations. J Am Podiatr Med Assoc. 2010;100(2):101-104.2. Armstrong DG, Boulton AJ. Pressure offloading and advanced wound healing: isnt it finally time for an arranged marriage? Int J Low Extrem Wounds. 2004; 3(4):184-187.3. Snyder RJ, Kirsner RS, Warriner RA, Lavery LA, Hanft JR, Sheehan P. Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes. Ostomy Wound Manage. 2010; 56(4 Suppl):S1-24.4. Sen RK, Murthy N, Gill SS, Nagi ON. Bacterial load in tissues and its predictive value for infection in open fractures. J Orthop Surg. 2000; 8(2):1-5.5. Rogers LC, Bevilacqua NJ, Armstrong DG. The use of marrow-derived stem cells to accelerate healing in chronic wounds. Int Wound J. 2008; 51(1):20-25.6. Attinger CE, Bulan E, Blume PA. Surgical debridement: the key to successful wound healing and reconstruction. Clin Podiatr Med Surg. 2000; 17(4):599-630.7. Armstrong DG, Lavery LA. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005; 366:1704-1710.8. Cardinal M, Eisenbud DE, Armstrong DG, et al. Serial surgical debridement: a retrospective study on clinical outcomes in chronic lower extremity wounds. Wound Rep Regen. 2009; 17(3):306-311.

Suture-less Vascular Anastomosis:Entering a New Era in Limb Salvage

PV Mayer — 25 Sep 2011 04:38:23 EST

Researchers Develop Method of Joining Blood Vessels Without Suturesby SCOTT JUNG on Aug 29, 2011 � 3:08 pmNo CommentsFor 100 years, the process of vascular anastomosis has largely been the same. Surgeons take a needle and thread and delicately suture together the walls of the blood vessel. Though literally sewing together blood vessels is a widely utilized surgical procedure, it isnt without its issues. Intimal hyperplasia, a cell response to the trauma of the needle and thread, causes blood vessels to narrow which increases the risk of a blood clot or localized turbulence. Sutures may trigger an immune response that causes dangerous inflammation. Moreover, suturing becomes extremely challenging on blood vessels that are less than one millimeter in diameter.Microsurgeons at Stanford University have developed a new method of vascular anastomosis that is safer and faster. The key ingredient in this new process is Poloxamer 407, a unique, FDA-approved polymer whose properties can be reversed by heating. In the case of vascular anastomosis, Poloxamer 407 is injected at the site where the blood vessels are to be joined, and the area is heated. The unique properties of Poloxamer 407 cause it to become elastic and solid when heated above body temperature. This causes both openings of a severed blood vessel to become distended, allowing surgeons to precisely join the openings together with Dermabond, a commonly used surgical sealant. After the blood vessels have been joined, a decrease in temperature causes Poloxamer 407 to dissolve harmlessly into the bloodstream.The process has been successfully demonstrated on blood vessels as small as 0.2 millimeters. If successful, the process could ultimately improve patient care by decreasing amputations, strokes and heart attacks while reducing health-care costs.Press release from Stanford University: Stanford researchers invent sutureless method for joining blood vesselsJournal abstract in Nature Medicine: Vascular anastomosis using controlled phase transitions in poloxamer gels

Oxygen MicroGenerators to Treat Ischemic Wounds?

PV Mayer — 25 Sep 2011 04:34:33 EST

Implantable Oxygen Generators Help Fight Cancerby BRIAN KLEIN on Aug 31, 2011 � 12:47 pm1 CommenA couple of days ago, we ran a blog post on an implantable oxygen sensor for monitoring tumor growth. In related news, researchers at Purdue University are developing an implantable device using a similar approach to treat tumors. But instead of monitoring oxygen, the device generates the gas in order to boost the effectiveness of chemotherapy and radiation treatment. The technology generates oxygen through water electrolysis.The device targets tumors that are hypoxic, meaning having low levels of oxygen. Hypoxic tumors are difficult to treat using radiation therapy because oxygen amplifies the effectiveness of radiation by helping to form free radicals, which damage a tumors genetic material. So the hypoxic areas [of tumors] are hard to kill, says Babak Ziaie, a Purdue professor who led the research. Pancreatic and cervical cancers are notoriously hypoxic. If you generate oxygen you can increase the effectiveness of radiation therapy and also chemotherapy, he adds.Ziaie reports that his father is a cancer survivor, who went through many rounds of painful chemotherapy treatment. This is a new technology that has the potential to improve the effectiveness of such therapy, he says.In testing on mice, the research group showed the oxygen generators are effective in treating pancreatic tumors. Measuring less than one centimeter in length, the generators were inserted into tumors using a hypodermic biopsy needle.Press release: Tiny oxygen generators boost effectiveness of anticancer treatmentAbstract in IEEE Transactions on Biomedical Engineering: An Ultrasonically-Powered Implantable Micro Oxygen Generator (IMOG).

Who Says That Wound Care Isn't Sexy: Wounds Get Wet Before They Get Hot

PV Mayer — 25 Sep 2011 12:29:56 EST

2 CommentsBruin Biometrics Sub-Epidermal Moisture Scanner Might Detect Decubitus Ulcers Before They Show Upby GAVIN CORLEY on Sep 6, 2011 � No CommentsBruin Biometrics, LLC, a wireless health technology company, and researchers at UCLA have developed a device for measuring the risk of pressure ulcer formation. The Sub-Epidermal Moisture (SEM) scanner is a handheld device which measures the dielectric properties of the tissue being assessed and provides an estimation of the sub-epidermal moisture which is indicative of risk of decub ulcer formation. The SEM scanner is designed to overcome current difficulties with visual pressure ulcer assessments by detecting early pressure damage before it becomes visible on the skin surface.The scanner is intended for use in a point of care environment and can wirelessly transmit measured data for storage and analysis on Bruin Biometrics proprietary back end system. The video below gives a nice overview of the early clinical work on SEM that led to the development of the system. It also has some nice technical info and shots of the device itself (techies scroll to 3:30). The SEM scanner was officially unveiled in April of this year and is expected to be commercially launched in the coming months.Product page: Bruin Biometrics SEM Scanner�

FREMS as a Novel Therapy for treatment of DFU

PV Mayer — 25 Sep 2011 12:18:56 EST

Case Presentation and Conclusion: A Novel Therapy for Treatment of a Diabetic Ulcerationby Conway T. McLean, DPM Conway T. McLean, DPMDirector of Podiatric SurgeryCottage ClinicsChicago, IL A diabetic patient presented to the office with a common presenting complaint, a non-healing wound. Like so many individuals with diabetes, this particular patient's level of self-care (as well as their understanding of the disease) was somewhat lacking. A limb-threatening infection had developed of the left foot, due, at least in part, to inappropriate care. Relevant medical history included a five year history of a charcot foot deformity of the right tarsus.The motor changes associated with this patient's neuropathy manifested in hammertoe deformities, which predictably led to a distal digit ulceration. A better informed diabetic would have sought care sooner, well before the ulcer had developed into osteomyelitis. Thus, a primary causative agent, it might be argued, was a lack of education.The patient presented to the office three weeks after the development of the digital ulceration. He had received minimal care prior to his arrival, consisting of simple wet-to-dry guaze dressing changes.click image set to enlargeUlceration at first post-op check following debridement of infected bone and non-viable soft tissue, appropriate wound care.Physical ExamInitial assessment naturally included evaluation of the wound, vascular status and neurological function, and radiographs. Arterial doppler studies revealed patent pedal vessels, although skin perfusion was reduced, likely due in part to excessive edema with induration of soft tissues. The ulceration itself was fairly typical for the clinical situation, with surrounding hyperkeratosis, the presence of mild amounts of purulence, and gross enlargment of the digit. No actual pain was reported by the patient secondary to neuropathy, nor were systemic signs of infection evident, as is so often the case with a localized diabetic infection.Musculoskeletal exam revealed contracture of the lesser digits with increased pressures to the distal aspect of the 3rd digit left. As is the pathogenesis of this condition, mild, non-infectious erythema led to the development of hyperkeratosis. The insensate patient will experience minimal to no symptoms, and only attuned health care specialists will be aware of impending events.Plain film radiographs revealed osseous changes consistent with osteomyelitis, including cystic changes, fragmentation and osteolysis.click image set to enlargeDigit after debridement and excision of osteomyelitic bone and one FREMS treatment.Treatment ConsiderationsUnfortunately for many diabetics, the terrible triad of immunopathy, neuropathy and vasculopathy combine to create very real and formidable obstacles to healing. We are held captive by the blood flow is a very apt saying, and though this individual had sufficient large vessel flow, signs of inadequate perfusion due to microvasculopathy were noted, included hair loss and atrophic epithelium.. The most obvious and accepted therapies, which were utilized here, include debridement of necrotic bone and soft tissue, moist wound healing, and appropriate antibiosis.click image set to enlargeUlcerated digit demonstrating progressive healing following seven FREMS treatmentsUnique TreatmentUtilized in this case was a very new, unique form of electrical stimulation, which employs high negative potential, single-phase electric current pulses, with suitably modulated frequencies and very short durations. These pulses are regulated in frequency, intensity, duration and potential, and act on the surface as well as the deep tissues. FREMS (Frequency Rhythmic Electrically Modulated Stimulation) was designed to take advantage of the belief that the summation of sub-threshold electrical stimuli, conveyed through the skin proximal to a motor nerve in a non-invasive system, would induce composite motor action potentials in excitable tissues.This is in stark contrast to a single, low-intensity impulse of brief duration, such as the one delivered by TENS. This is unable to overcome the dielectric skin barrier and thus will not excite the underlying nervous and/or muscle to elicit a recordable motor action potential (MAP). The signal of the FREMS is quite different. Through a specific sequence of weak impulses, with a rapid increase and decrease in pulse frequency and duration, there is a gradual recruitment of MAP in the stimulated tissues.The patient's wound closed quickly and progressively, without interruption. An additional benefit to this patient was the associated improvement in sensorium. Because the therapy was utilized to treat the ulceration, it was performed unilaterally. The increase in sensation, as compared to the untreated side, was reported by the patient with signs including improved two point discrimination, vibratory sensation, monofilament detection. Also importantly, this benefit continued, with minimal loss, for eleven months.The science and art of wound care has developed rapidly as a field of study in the last few decades. This is evidenced by the explosion of new products and materials now available. Many adjunctive treatments have been developed, with more recent advances including negative pressure wound therapy, hyperbaric oxygen therapy and biological living skin equivalents.The FREMS device has been shown through numerous double-blind studies to have several significant and important effects. For example, there are changes in the perfusion velocity in the microcirculation, as well as inducing a long-acting increase in vasomotor activity (with significant changes noted at four months post treatment).Some other effects are an increase in the release of growth factors including VEGF, increased blood flow and capillary density encouraging the formation of new granulation tissue. Additionally, there is a significant increase in nerve conduction velocity(MNCV) and a statistically significant reduction of pain after FREMS. On average, at the end of active treatment, MNCV was increased by almost 5 m/s; vibration perception threshold was reduced by more than 2 V; and the number of foot points insensitive to the Semmes Weinstein monofilament was decreased.In this case, healing progressed rapidly upon initiating the FREMS, while the usual armamentarium of antibiosis, appropriate debridement and proper wound care were employed. Osteomyelitic bone was resected during the course of FREMS treatments (typically consists of ten sessions). The presence of infection is not a contraindication to its use, and it seems likely that FREMS aids the process of bacterial eradication by increasing perfusion.click image set to enlargeOsteomyelitic metatarsal head excision site healing via secondary intention.Immunopathy is an important component of the lower extremity problems experienced so frequently by people with diabetes. Yet vasculopathy and neuropathy may be considered the more devastating mechanisms, which lead so often to limb loss, disability, and a drastic reduction in quality of life. Those studies performed to date appear to indicate that we have a new and powerful tool that may significantly alter the natural history of this condition, leading to morbidity and mortality. No side effects or complications from it's use have been experienced, and though perhaps not all will experience such dramatic effects as this patient did, it appears certain that this modality has the potential to drastically change the outcomes of diabetic patient care and maintanence.Sincerely,###REFERENCES:Barrella M, Toscano R, Goldoni M, Bevilacqua. Frequency rhythmic electrical modulation system (FREMS) on H-reflex amplitudes in healthy subjects. Eura Medicophys 2007, 43: 37-47.Bevilacqua M, Barrella M, Toscano R et al (2004) Disturbances of vasomotion in diabetic (type 2) neuropathy: increase of vascular endothelial growth factor, elicitation of sympathetic efflux and synchronization of vascular flow (vasomotion) during frequency modulated neural stimulation (FREMS). 86th Annual Meeting of the Endocrine Society, p 321, P 2 61 (abstract)Bevilacqua M., Baruffaldi L., Foddis L., Toscano R., Vago. Increase of Vascular Endothelial Growth Factor by Electrical Stimulation with High Varialbility in Frequency and Amplitude: a clinical study in non-insulin dependent diabetics with limb ischemia. 85th International Congress of Endocrine Society, Philadelphia, June 2003Bevilacqua M. et al. Increase of Vascular Endothelial Growth Factor (VEGF) by FREMS. A clinical study in Non-Insulin Dependent Diabetics with Limb Ischemia. Presented at ENDO 2003 Endocrinology Societys 85th annual meeting Philadelphia.Bosi E, Conti M, Vermigli C, et al. Effectiveness of a novel frequency modulated electro-magnetic neural stimulation in the treatment of painful diabetic neuropathy. Diabetologia 2005, 48: 817-23Ciancia, et al. Diabetic plantar ulcer treated with an innovative thearpy - FREMS (frequency modulated electro-magnetic neural stimulation). Italian Society of Gerontology and Geriatics, Florence; Palazzo Congressi 9-13 November 2005Combi F. Application of novel neuromodulation for skeletal muscle regeneration following chronic fobrosis process. The Rehabiliation of Sports Muscle and Tendon Injuries-Milano April 2004Conti M., Peretti E., Cazzetta G., Folini L., Vermigli C., Galimberti G. Frequency modualted electromagnetic neural stimulation enhances cutaneous microvascular perfusion in patients with diabetic neuropathy. 42nd Annual Meeting of the European Association for the Study of Diabetes, Copenhagen Sept. 2006Da Ros R., C. Vitale, R. Assaloni, A. Ceriello Neuromodulation FREMS in the treatment of diabetic peripheral arterial disease. 42nd Annual Meeting of the European Association for the Study of Diabetes, Copenhagen Sept. 2006Facchini M.G., Mambelli E., Checchia G., Gaggi R., Santoro A., The Lorenz Therapy: a new tool in the treatment of uremic neuropathy. European Dialysis and Transplant Association, Lisbona May 2004.Farina S., Casarotto M., Benelle M., Tinazzi M., Fiaschi A., A randomized controlled study on the effect of two different treatments (FREMS and TENS) in myofascial pain syndrome. EUR MED PHYS 2004; 40:293-301Guggi S, Cavina U. Experience of a novel transcutaenous neuromaodulation as first approach to muscle injuries. XIV International Congress on Sports Rehabilitation and Traumatology, Bologna 2005Kumar D, Marshall HJ (1997) Diabetic peripheral neuropathy: amelioration of pain with transcutaneous electrostimulation. Diabetes Care 20:1702 1705Scionti L., Conti M., Vermigli C., Cazzetta G., Galimberti G., Bosi E. A new treatment for painful diabetic neuropathy: the Frequency Modulated Neural Stimulation (FREMS). NEURODIAB, Resensburg, GermanyZhao M. Bai H, Wang E, Forrester J.V., McCaig CD. Electrical stimulation directly induces pre-angiogentic responses in vascular endothelial cells by signaling through VEGF receptors. J Cell Sci 2003:117.395-405.Lorenz NeuroVasc is a Canadian company operating as the exclusive supplier of FREMS� technology to the North American healthcare industry.FREMS� technology is the product of Lorenz Biotech S.p.A. of Modena, Italy, and is rapidly being adopted as a preferred treatment option in the European markets. � Products �FREMS� is a composition of electrical signals characterized by negative and multi-modulated pulses which mimic different electrophysiological processes.Aptiva� Ballet is the ideal device for the treatment and clinical research of peripheral nervous and vascular systems diseases.Aptiva� Move is the portable and flexible choice in rehabilitation.To learn more about Lorenz Neurovasc and its products and services, visit www.lorenzneurovasc.ca or call toll free at 1.866.443.8567.

You Can't Manage What You Can't Measure

PV Mayer — 02 Sep 2011 06:48:26 EST

Translation Tool Deepens Data PoolBY JOHN PULLEY 07/13/11 02:56 pm ETA partnership between the Mayo Clinic and the minds behind IBM's Watson technology is close to completing development of tools to mine data from electronic health records that speak different digital languages.The goal is to safely and securely convert stores of electronic health records into a bottomless pool of real-world clinical knowledge, the Mayo Clinic says in a news release. Reaching that goal requires the ability to glean information from a variety of EHRs that tag and store clinical information in different, often proprietary, digital formats.So far, investigators with the Mayo-led team have used natural language processing tools to pull information from the records of 30 patients with diabetes and run it through computing systems developed with IBM's Watson Research Center, a process that transforms the data into 134 billion pieces of information, according to the clinic. (Watson is the language-recognition computer that recently won a Jeopardy. challenge against two of the game show's best human players.)HHS believes that mining EHRs for clinical information can lead to improved care by allowing researchers to learn from trends and treatment successes across the country.This gets to the heart of meaningful use, says Lacey Hart, Mayo's SHARP administrator, in the news release. It's one thing to meet the government requirement that you should have an electronic record, but it's another thing, once you have that record, to make meaning out of it.The project is one of four funded by the $60 million Strategic Health ITAdvance Research Project (SHARP) program, an initiative of the U.S. Department of Health and Human Services through its Office of the National Coordinator for Health IT.

An Excellent Case Study on the Diabetic Heel Ulcer by Dr. Jay Lieberman

PV Mayer — 02 Sep 2011 06:20:26 EST

Case Presentation: Decubitus Ulcer at Its Worst by Jay LiebermanDPM, FACFAS Decubitus ulcers are caused by pressure, sheer, and friction. The patient presented here had compromised blood flow. The additional pressure on the heel deformed the vascular bed and precipitated the necrosis/ischemia. If a decubitus ulcer is stable, my protocol is to evaluate the vascular status, hydrate anhydrotic skin, address any potential infections, optimize nutrition, offload the area (preventing friction and sheer), and have the patient ambulate if possible.This 54-year-old insulin dependent diabetic was initially treated for a sterile bullae on the posterior aspect of the left heel. There was no precipitating acute trauma or thermal injury. PAST MEDICAL HISTORY: This includes hypertension, diabetes, peptic ulcer and osteoarthritis.MEDICATIONS: Catapres, Lovenox, Insulin, Zestril, Lisinopril and Reglan.ALLERGIES: PercocetFAMILY HISTORY: Diabetes, history of GI bleed.SOCIAL HISTORY: Previous history of smoking, ceased more than ten years ago.SURGICAL HISTORY: The patient has had left toe amputation, right ankle surgery times two, cholecystectomy and trigger finger release.Activity LevelTREATMENT AND COURSEAfter two weeks, the bullae dried into a gangrenous eschar with minimal moist necrosis in the deeper layers. The eschar was loosely adhered to the heel. The patient was seen weekly for debridement of devitalized tissue. A LNard splint was utilized to offload the area. Home healthcare did daily assessments and applied enzymatic debridement agents with dressing changes.This patient slowly developed a poor quality granulating base. Although there was some evidence of improvement, new areas of necrosis were seen. After some time, a component of the Achilles tendon could be visualized. Her pain level was between a 5 or 6 out of 10, giving a high suspicion that ischemia was a larger component of the problem than originally thought.The patient was sent for a vascular evaluation. Peripheral flow to her leg was marginal at best. Stent placement would be considered, only if the wound would not heal, as patient was not an ideal candidate for surgical intervention. The arterial Doppler suggested partial occlusion of the femoral artery with calcifications in the distal branches. Two months after the initial presentation, the patient came to the office with large bullae formation along the medial and lateral walls of the calcaneus. Infectious Bullae Medial Wall (post debridement)Bullae Lateral Wall (post debridement)Moist necrosis Heel with MRSAErythema, fluctulance and drainage were readily apparent. Cellulitis and lymphangitis were noted. Cultures taken at that time indicated a MRSA infection. The patient was admitted to the hospital and started on Vancomycin. An MRI indicated marrow signal changes in the posterior calcaneus compatible with osteomyelitis. Standard x-rays showed loss of normal cortical structure. MRI Standard RadiographHospital AdmissionUpon admission, the patients WBC was 22, 000. Blood glucose was 360. Blood cultures were negative. After 48 hours, a partial calcanectomy was performed with wound debridement. Postoperatively negative pressure wound therapy was initiated. VAC in place2nd Hospital AdmissionDuring a subsequent hospitalization, stents were placed in the left leg. The quality of the granular bed improved markedly over the next two to three weeks. Ultimately, a GRAFTJACKET� t was applied to the heel to further promote healing. Below is the most recent photograph showing the patient at one month status post surgery.GRAFTJACKET� AppliedGRAFTJACKET� from KCIOne month post-op Two month post-op 10 weeks post-opAt this point the options available to us are:Hyperbaric Oxygen Therapy to promote further neovascularizationDebridement of undermined tissue with second application of synthetic skinDebridement of undermined tissue with direct application of split thickness skin graftApplication of silver dressing to decrease bacterial load

A Tribute to the Master: Dr. Paul Brand

PV Mayer — 02 Sep 2011 06:17:16 EST

Paul Brand Missionary and PioneerAt this year's Desert Foot Multidisciplinary High Risk Foot Seminar (Nov 16- 18, AZ Grand Resort in Phoenix) we will be honoring a true legend with the inauguration of our Annual Paul Brand Memorial Lectureship. Some of you may have no idea who this remarkable man was (even though you all practice with the principles that he taught us). If you treat a neuropathic foot, you are approaching that high risk foot with the guidance that Dr Brand offered over his many years of practice and writings.Paul Brand, MD7/17/1914 - 7/8/2003Paul Brand, MD (July 17, 1914 - July 8, 2003)was a Christian Missionary working in Vellore, India at a Leprosy Mission for many years (1946-1966). A trained Orthopaedic Surgeon, Dr. Brand, who grew up the son of English missionaries to South India, achieved world renown for his research on leprosy and related research on the dynamics of pain. He was a pioneer in developing tendon transfer techniques for use in the hands of those with leprosy (Hansen's Disease). He was the first physician to appreciate that leprosy did not cause the rotting away of tissues, but that it was the loss of the sensation of pain which made sufferers susceptible to injury.

Bulletproof Skin: Just what we(DFU Docs) were looking for.

PV Mayer — 25 Aug 2011 02:46:42 EST

Human Skin, Made (Semi-)Bulletproofby BRIAN KLEIN on Aug 23, 2011 � 5:27 pm1 Comment8inShareHeres an unusual story. As part of a bio-art project, Dutch artist Jalila Essa�di collaborated with the Forensic Genomics Consortium Netherlands with the goal of developing bulletproof skin. To accomplish this, the scientists merged human skin cells with spider silk harvested from transgenic goats. In tests, the skin proved to be strong enough to stop a .22 caliber bullet fired at a reduced speed. It didnt succeed, however, in repelling a bullet fired at full speed. Despite that setback, such skin could eventually be used for an array of medical applications, including burn and wound treatment, and tendon and ligament repair.Vastly stronger than steel, spider silk is notoriously difficult to come by; harvesting the material from arachnids is complicated by the fact that the creatures are both highly territorial and cannibalistic. For that reason, the silk used for this application was made from genetically engineered goats that excreted silk protein in their milk.The skin created for this project features a spider-silk matrix sandwiched between a dermis and epidermis layer.The skin is on display at the National Natural History Museum in Leiden, Netherlands.A video explaining how silk was harvested from milk from transgenic goats:And for our Dutch speakers, heres more about the silk with time at the gun range:Artists description of the bulletproof skin: 2.6g 329m/sMedgadget posts you might like:

Neuropathic Feet Need Steady Activity

PV Mayer — 02 Aug 2011 06:20:36 EST

Take Home Message: Be ConsistentThanks to SALSA grad Tim Fisher for finding and tweeting this from his home in the UAE . It's work from Robert Gabbay from Penn State reviewed in MedPage today. Enjoy. _________________By Kristina FioreDiabetes patients enrolled in a medical home program supported by multiple payers saw improvements in several aspects of their care, researchers say.A study of 10,000 patients who had been in the program for a year found that the percentage of patients who had yearly foot assessments for neuropathy rose from a baseline 50% to 69%, according to Robert Gabbay, MD, PhD, of Penn State University, and colleagues.In addition, more patients got yearly screenings for nephropathy and diabetic retinopathy, and there was also an increase in pneumonia and flu shots over baseline, the investigators reported in the June issue of the Joint Commission Journal on Quality and Patient Safety.Providers also made greater use of therapies shown to reduce morbidity and mortality: the proportion of patients on statins jumped from 36% to 57% after initiation of the program, while those on either an ACE inhibitor or an angiotensin receptor blocker (ARB) rose from 42% to 56% (P<0.05 for both).Gabbay and colleagues lamented the fact that only 7% of diabetes patients currently achieve evidence-based goals for key predictors of morbidity and mortality, including glycated hemoglobin (HbA1c), blood pressure, and lower LDL cholesterol.Further improvements likely require a paradigm shift, they said, which may be found in the Chronic Care Model incorporated into the Patient-Centered Medical Home.The patient-centered medical home concept involves a team-based model of care, led by a primary care doctor who provides coordinated care throughout a patient's lifetime. The chronic care model focuses on multiple elements that enhance the relationship between patients with chronic conditions and their medical team, including greater support for self-management, improved clinical information systems, making community resources available, and offering decision support.Gabbay and colleagues initiated one of the first medical home centers that incorporates the chronic care model for diabetes patients, initially encompassing 25 practices and 143 primary care providers covering about 10,000 diabetes patients in southeast Pennsylvania. Their model was unique, they said, because it incorporates multiple payers -- six of the state's private insurers.Since there haven't been any data reported on this type of medical home, Gabbay and colleagues analyzed the program's first year, from May 2008 to May 2009.During that time, they said they saw significant improvement in both evidence-based care guideline adherence and clinical outcomes.Gabbay and colleagues also reported small but statistically significant improvements in key clinical parameters such as blood pressure and cholesterol, although they noted the greatest improvements occurred in the highest-risk patients:An 8.5% absolute increase in the percentage of patients with an LDL cholesterol level under 130A 4% absolute increase in those with blood pressure under 140/90A 2.5% drop in the proportion of patients with HbA1c above 9%They noted that said these effects may have been the result of the fact that the initiatives focused on high-risk patients in order to reduce the number of people with the poorest diabetes quality measures.It's also possible that some of the assessed performance improvement could be attributed to better data collection, documentation, and reporting, they wrote.As well, improvements in complication screening resulted, in many cases, from distributing tasks among the healthcare team, they said.The study was also limited by self-reported data, but overall the researchers said the program has already been expanded to include 152 practices and 644 providers.Similar, multi-payer initiatives began after this initiative -- in Colorado, Rhode Island, and Vermont -- but Gabbay and colleagues noted that there are differences in their design and said it will be important to understand how these differences affect the effectiveness of the patient-centered medical home efforts.Posted by David G. Armstrong at 8:27 AMReactions: 0 comments Neuropathy and Exercise: NOT mutually exclusive (...so get moving)Superb article in today's Lower Extremity Review (online) by Cary Groner. He does a wonderful job in synthesizing works from a variety of research teams that come up with similar conclusions: if you don't use it, you lose it. Enjoy:A classic case of innovative research turning conventional wisdom on its head is changing the way clinicians approach exercise in patients with diabetic neuropathy.For decades, patients with type 2 diabetes and peripheral neuropathy were cautioned against weight-bearing exercise out of fear that the accompanying stress on the foot would lead to plantar ulcers. Then, in 2003, scientists began to report surprising findings.Prior to those studies, the feeling was that weight-bearing exercise was too risky to recommend to patients who lacked sensation, said Joseph LeMaster, MD, MPH. LeMaster, for many years an associate professor in the Department of Family and Community Medicine at the University of Missouri, will move to the University of Kansas this fall. There was evidence that people with neuropathy had increased plantar pressures, and those were considered an independent risk factor for foot ulcers.In 2003, LeMaster and his colleagues published a study of 400 diabetes patients with a history of foot ulcers and found that increased weight-bearing activity didn't increase the risk of reulceration. Moreover, the most active subjects saw the most significant risk reduction, and the effects were the same regardless of whether subjects retained foot sensation.1istockphoto.com#525339That same year, researchers from Washington University in St. Louis reported in Clinical Biomechanics that diabetes patients with a history of plantar ulcers were 46% less active and accumulated 41% less daily stress on the forefoot than nondiabetic and diabetic control subjects without a history of such ulcers.2 At first, the finding seemed so counterintuitive that people weren't sure what to make of it. The authors ultimately concluded, conservatively, that subjects with a history of plantar ulcers were susceptible to injury at relatively low levels of tissue stress.These studies flung open the door to further investigations, however. In 2004, scientists confirmed in Diabetes Carethat neuropathic patients who exercised more had lower rates of ulceration than those who were relatively sedentary.3 Two years after that, in 2006, researchers in Italy reported that, far from being deleterious, exercise could help prevent neuropathy's onset or modify its natural history.4 Right on cue, then, in 2008, Washington University researchers reporting on the Feet First study noted that promoting weight-bearing activity did not lead to significant increases in foot ulcers.5 Finally, in 2010, the American Diabetes Association, together with the American College of Sports Medicine, acknowledged this accumulating body of evidence and published new guidelines that, for the first time, endorsed weight-bearing exercise for patients with diabetic neuropathy in the absence of foot ulcers.6The new guidelines represent a big change, said Michael Mueller, PT, PhD, a professor of physical therapy at Washington University School of Medicine. For the first time, people with diabetic neuropathy are explicitly encouraged to do weight-bearing exercise.Although this rhythmic chronology outlines what appears to be a straightforward investigation that changed medical practice, the story is more nuanced. A number of questions have bedeviled researchers, and continue to. For example, what's the chicken and what's the egg? That is, do people get more ulcers because they get less exercise, or do they exercise less because of their ulcer history? Or, for that matter, are other variables involved that no one yet understands? These and other issues, such as how to distinguish those at highest risk of ulceration from their peers and how to adjust exercise regimens accordingly for individual patients, are only now starting to become clear.Foundationsistockphoto.com#2184298Back in 2002, Mueller published a paper in Physical Therapywhose relevance to this issue was not immediately clear, but which turned out to have a big impact. In that article, he proposed a Physical Stress Theory (PST) of tissue adaptation, the premise of which was that changes in the relative level of physical stress cause a predictable adaptive response in biological tissues.7 In a nutshell, the theory suggests that tissues respond to stress in predictable ways: stress levels that are too low lead to reduced stress tolerance and atrophy; mid-level stress produces no change; moderately high levels increase tolerance; and too much stress leads to injury and tissue death. The goal for practitioners seeking to increase their patients' strength and resilience was to identify the levels that increased tolerance and work carefully from there.Mueller also made several points that affected later researchers:1. Stress exposure is a composite value comprising magnitude, time, and direction of stress application.2. Extreme deviations from the maintenance stress range have serious consequences.3. Individual stresses combine in complex ways to contribute to the overall level of stress exposure, and tissues are affected by the history of recent stresses.4. Excessive stress can arise due to a brief, high-magnitude stress; a long duration of low-magnitude stress; or a repetitive application of moderate stress.5. Inflammation occurs immediately after injury, reduces the injured tissue's stress tolerance, and requires that the tissue be protected from further stress until the inflammation subsides.Many of these points turned out to be crucial to understanding how to manage diabetic neuropathy in the context of exercise.VariabilityThe lead author of the 2004 study in Diabetes Care was David Armstrong, DPM, MD, PhD, professor of surgery and director of the Southern Arizona Limb Salvage Alliance (SALSA) at the University of Arizona College of Medicine in Tucson. An important aspect of his team's findings was not just that more active subjects were less prone to ulcers, but that variability in activity was an important predictor of ulcer risk. Eight of 100 patients with diabetic neuropathy ulcerated during the average evaluation period of 37 weeks, and although they were significantly less active than those who remained ulcer-free, there was also much more variability in their exercise levels, as measured by high-capacity computerized accelerometer/pedometers.People who had wide swings in activity were at greater risk, Armstrong told LER. An example would be someone who's not very active, then suddenly remembers their grandkid's birthday and leaps off the couch, runs to the car, then spends an hour and a half walking around the mall. They do more in a couple of hours than they usually do in two days.When Armstrong and his colleagues first evaluated their data, they were flummoxed.We sat there wondering what was going on, he said.Their conclusion, however, echoed Mueller's observations about the importance of tissue stress levels and the consequences of extreme deviation in them.We believe what we're seeing is that it's just like a lot of other places in the body, Armstrong explained. If you don't use it, you lose it. If skin is allowed to atrophy, then maybe it's weaker than skin that's getting tenderized, as it were, by frequent activity.Armstrong noted that patients must be monitored carefully, as they were in his study, and that exercise has to be optimized for the individual.People can't run a marathon with profound neuropathy, but we'd like to try to train them so they could slowly become more active, he said. We want to dose activity the way you'd titrate a drug.As for the chicken-and-egg problem�which comes first, the ulcer or the lower activity levels?�researchers are continuing to probe the reasons first ulcers appear. Manish Bharara, PhD, a research assistant professor at SALSA and a colleague of Armstrong's, speculated that overall control of blood glucose levels may affect the resilience of damaged tissues.In diabetes patients, metabolic control affects other aspects of physiology, and could affect the quality of the tissue that is regenerated as someone heals, he said.A couple of Armstrong's earlier papers may shed light on the issue, as well. In a 2001 article in the Journal of the American Podiatric Medical Association, Armstrong and his colleagues noted that diabetic patients with a history of neuropathy or ulceration took more steps per day inside the home than outside, and that only 15% of them wore their prescribed footwear inside.8 A paper in Diabetes Care in 2003 reported that subjects with foot ulcers wore their off-loading devices for only a minority of steps taken each day.9 Noncompliance with preventive footwear or curative devices could conceivably be similar in effect to low activity levels, then, in that both are associated with ulceration and poor healing. One possible explanation is that, compared to high-activity patients, low-activity patients are taking significantly fewer steps per day in footwear designed to help their feet avoid injury or heal (activity studies have not consistently reported compliance data).It even turns out that sometimes just standing for long periods can be potentially dangerous, Armstrong noted.10 This is all about better identifying risk and helping us better coach activity. We're trying to get people moving, and in a lot of ways, that's how we measure success.Individual casesistockphoto.com#13698497The Feet First study made it clear that clinicians must carefully consider the patient's history when prescribing exercise, according to lead author LeMaster.In that study, we felt that the exercise program, combined with the careful monitoring we conducted, showed that the benefits of exercise outweighed the risks, he said. But it's quite another thing to say that people who have lots of recent foot ulcers should go out and do this. A good percentage of the people in the study had had prior ulcers, and we didn't find that to be a predictor [of ulceration during the trial]. But we restricted people from walking if they had any breakdown during the study.People with a history of frequent and recurrent ulcers, he added, should be viewed in a different category than those included in the research. Furthermore, the study's subjects had their feet examined weekly by a physical therapist for the first three months, and had a hotline to call if they showed signs of ulceration later.Mike Mueller, a coauthor of the 2008 Feet First paper, likened the evolving view of exercise in those with neuropathy to a similar evolution in thinking about exercise in cardiac patients a few decades ago.There was a time when the prevailing opinion was that if you'd had a heart attack, you should not exert yourself, Mueller said. We came to learn that if you monitor the heart carefully and keep it within a safe range, exercise is beneficial. It's similar with the neuropathic foot, although we're still learning what the guidelines should be.Adjusting exercise programs to the individual based on variables such as ulcer history is still an emerging field, he noted, and based both on the evidence provided by research and on clinical experience.I believe that once you've had a full-thickness ulcer, you're in a whole different category, he said. Even a mild one sends up a red flag that you'd better watch this person. There's so much heterogeneity in the group of people who have diabetes and neuropathy that the program really needs to be tailored to the individual.Joint biomechanicsPart of the problem with such tailoring is that only recently has research begun to describe the relationship between biomechanics and diabetic neuropathy.For example, a 2007 paper in the Journal of Applied Biomechanics found that diabetic subjects with neuropathy had stiffer ankles than diabetic subjects without neuropathy.11 It's known that normal mobility allows the foot to flexibly dissipate impact, then become rigid during push-off.12 Restricted mobility in the foot and ankle joints, then, could hinder this transition and contribute to abnormal plantar loads.13Citing such evidence, Smita Rao, PhD, an assistant professor of physical therapy at New York University, published a paper in 2006 outlining how changes in muscle could account for decreased range of motion (ROM) and increased stiffness in patients with diabetes.14 In a subsequent article inGait & Posture, she and her colleagues reported that decreased sagittal motion of the first metatarsal and lateral forefoot and frontal motion of the calcaneus were key elements that could contribute to increased, sustained plantar loading in patients with diabetes and neuropathy.15There's a big push to emphasize exercise in patients with diabetes and peripheral neuropathy, but those patients are also at higher risk for tissue breakdown, so I wanted to explore the mechanisms that put them at risk, Rao told LER. We showed in the Gait & Posture paper that a lot of these patients try to reduce the effects of their stiffness by walking slower and taking shorter steps. When I examine them, I want to look at ankle range of motion, all the mechanical factors that may affect tissue breakdown; but I also want to assess how they walk, find focal regions of high pressure, then put those two together to see if walking is the best activity for this person. Some might need protective footwear, and some should ride a stationary bike instead.In her current research, Rao and her colleagues at NYU are examining ways to bring a number of fields together.My grandfather had diabetes, so I have a personal connection to the field, she said. All these negative effects begin with high blood sugar, so we're trying to combine medical, surgical, and rehabilitative interventions in patients with diabetes and neuropathy.Exercise and balanceOther research has looked at the importance of augmenting exercise with balance training, which has been shown to improve clinical balance measures in neuropathic patients.16 A study published in Diabetes Care in 2010 demonstrated, moreover, that six weeks of such training reduced the risk of falls in 16 older patients with type 2 diabetes and mild to moderate neuropathy.17 In that research, exercise sessions included a balance/posture component (lower-limb stretches and leg, abdominal, and lower-back exercises) and a resistance and strength-training component using machines. The regimen led to better reaction times and affected sensory, motor, and cognitive processes, leading to a significant decline in risk of falls.Lead author Steven Morrison, PhD, director of research in the School of Physical Therapy at Old Dominion University in Norfolk, VA, told LER that his group's work was motivated partly by the fact that older diabetes patients' risk of falling is 10 to 15 times that of healthy age-matched controls, which affects their confidence and ability to exercise.To be balanced, you need a certain amount of strength and a certain amount of coordination, he said. We found that after six weeks of training, type 2 diabetic individuals become more like the control group�there's very little difference in terms of how much they sway and what their balance is like.Monitoringshutterstock.com#33362974David Sinacore, PT, PhD, a professor of physical therapy and medicine at Washington University, and one of the researchers involved in studies of exercise and neuropathy there, emphasized that monitoring�by clinicians or the patients themselves�is crucial to successful exercise programs in those with diabetic neuropathy, particularly if they also have foot deformities such as those resulting from Charcot arthropathy.I'm a firm believer that these folks need to exercise for their diabetes, he said. But if they start to develop lesions, they need to be addressed.Of course, as most clinicians know, there is often a gap between ideal and real-world monitoring levels.It's hard for these patients to check the bottom of their feet regularly, so they sometimes don't do it, Sinacore said.One way to help is with temperature monitoring. Sina�core recommends foot-temper�ature gauges that patients can use right after exercising, some of which are hook-shaped to ease plantar access.When we monitor them here, we check temperature before and after exercise, he said. We're looking for hot spots and temperature dif�ferences that may indicate that they're developing a lesion.In such cases, therapists recommend that patients de�crease their exercise levels for a while and have their footwear modified to relieve pressure.David Armstrong agreed that thermometry provides a way of keeping track of the damage caused by weight-bearing exercise.We want our patients to dose their activity by checking their skin temperature just as they dose their insulin by checking their glucose, he said.His colleague, Manish Bharara, conducts innovative research in this aspect of care.18In the last decade we've learned that a four-degree difference between two similar sites on both feet is an ulcer risk, he said. If the pattern persists over multiple days, the patient should reduce activity and immediately see a doctor.Bharara and his colleagues are developing a thermometry scale to address some of the inconveniences typically associated with measuring foot temperature at several sites. Patients stand on it�it's similar to a bathroom scale�while it measures foot temperature at 20 sites on each foot and records the data. The scale speaks to the patient�telling him, for example, that his right big toe temperature is 5� warmer than the left. Moreover, if the scale detects an abnormal pattern for more than two days, it can be programmed to send a message to the physician's office and make an appointment.Something like this could really help manage patients' diabetes better, because the biggest barrier is compliance, Bharara said.New researchOther researchers are examining variables that affect neuropathic patients' exercise capabilities, as well. For example, at the Center for Lower Extremity Ambulatory Research at Rosalind Franklin University in Chicago, Bijan Najafi, PhD, associate professor of applied biomechanics, has studied factors including gait initiation in this context.19 As opposed to the measures of steady-state walking�such as rate or number of steps�typically used in exercise studies, a prolonged gait initiation phase (the period between upright posture and steady-state gait) may be associated with increased fall risk.During the initiation of the step, there's an important acceleration phase, and it creates a lot of resistive force, Najafi said. We've found that neuropathy patients have longer gait initiation. This makes sense, because to reach steady-state gait, people have to gather somatosensory feedback to find the speed at which they can walk safely and minimize energy costs. Neuropathy patients have impaired somatosensory feedback, though. But we believe that if we can provide a good exercise to compensate, we may be able to improve the gait initiation phase.One way to help, Najafi thinks, is to take a cue from the dance world.If you're trying to explain a movement problem to a dancer he may not get it, but if you put a mirror in front of him and show him the correct position of the joints, he can improve his motor skills, he said. The brain is plastic, and if it realizes there's an error, it will try to minimize it next time. So we hope that by letting neuropathy patients observe their errors this way, they may improve their motor skills.Cary Groner is a freelance writer based in the San Francisco Bay Area.References1. LeMaster JW, Reiber GE, Smith DG, et al. Daily weight-bearing activity does not increase the risk of diabetic foot ulcers. Med Sci Sports Exerc 2003;35(7):1093-1099.2. Maluf KS, Mueller MJ. Comparison of physical activity and cumulative plantar tissue stress among subjects with and without diabetes mellitus and a history of recurrent plan for ulcers. Clin Biomech 2003;18(7):567-575.3. Armstrong DG, Lavery LA, Holtz-Neiderer K, et al. Variability in activity may precede diabetic foot ulceration. Diabetes Care 2004;27(8):1980-1984.4. Balducci S, Iacobellis G, Parisi L, et al. Exercise training can modify the natural history of diabetic peripheral neuropathy. J Diabetes Complications 2006;20(45):216-223.5. LeMaster JW, Mueller MJ, Reiber GE, et al. Effect of weight-bearing activity on foot ulcer incidence in people with diabetic peripheral neuropathy: Feet First randomized controlled trial. Phys Ther 2008;88(11):1385-1398.6. Colberg SR, Sigal RJ, Fernhall B, et al. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association joint position statement. Med Sci Sports Exercise 2010;42(12):2282 2303.7. Mueller MJ, Maluf KS. Tissue adaptation to physical stress: a proposed physical stress theory to guide physical therapist practice, education, and research. Phys Ther 2002;82(4):383-403.8. Armstrong DG, Abu-Rumman PL, Nixon BP, Boulton AJ. Continuous activity monitoring in persons at high risk for diabetes related lower-extremity amputation. J Am Podiatr Med Assoc 2001;91(9):451-455.9. Armstrong DG, Lavery LA, Kimbriel HR, et al. Activity patterns of patients with diabetic foot ulceration. Diabetes Care 2003;26(9):2595-2597.10. Najafi B, Crews RT, Wrobel JS. Importance of time spent standing for those at risk of diabetic foot ulceration. Diabetes Care 2010;33(11):2448-2450.11. Williams DS 3rd, Brunt D, Tanenberg RJ. Diabetic neuropathy is related to joint stiffness during late stance phase. J Appl Biomech 2007;23(4):251-260.12. Saltzman CL, Nawoczenski DA. Complexities of foot architecture as a base of support. J Orthop Sports Phys Ther 1995;21(6):354-360.13. Mueller MJ, Diamond JE, Delitto A, Sinacore DR. Insensitivity, limited joint mobility, and plantar ulcers in patients with diabetes mellitus. Phys Ther 1989;69(6):453-459.14. Rao SR, Saltzman CL, Wilken J, Yak HJ. Increased passive ankle stiffness and reduced dorsiflexion range of motion in individuals with diabetes mellitus. Foot Ankle Int 2006;27(8):617-622.15. Rao S, Saltzman CL, Yack HJ. Relationships between segmental foot mobility and plantar loading in individuals with and without diabetes and neuropathy. Gait Posture 2010;31(2):251-255.16. Richardson JK, Sandman D, Vela S. A focused exercise regimen improves clinical measures of balance in patients with peripheral neuropathy. Arch Phys Med Rehabil 2001;82(2):205-209.17. Morrison S, Colberg SR, Mariano M, et al. Balance training reduces falls risk in older individuals with type 2 diabetes. Diabetes Care 2010;33(4):748-750.18. Bharara M, Cobb JE, Claremont DJ. Thermography and thermometry in the assessment of diabetic neuropathic foot: a case for furthering the role of thermal techniques. Int J Low Extr Wounds 2006;5(4):250-260.19. Najafi B, Miller D, Jarrett BD, Wrobel JS. Does footwear type impact the number of steps required to reach gait steady-state?: An innovative look at the impact of foot orthoses on gait initiation. Gait Posture 2010;32(1):29-33.

New Exercise Recommendations for Treating Type 2 Diabetes

PV Mayer — 02 Aug 2011 04:44:55 EST

New Guidelines for Exercise in Type 2 DiabetesNew guidelines stress the crucial role that physical activity plays in the management of Type 2 diabetes: physicians should prescribe exercise....They replace recommendations made in the American College of Sports Medicine Position Stand, Exercise and Type 2 Diabetes, issued in 2000.Developed by a panel of 9 experts, the new guidelines are published concurrently in the December issue of Medicine & Science in Sports & Exercise and Diabetes Care.High-quality studies establishing the importance of exercise and fitness in diabetes were lacking until recently, the expert panel writes, but it is now well established that participation in regular physical activity improves blood glucose control and can prevent or delay Type 2 diabetes mellitus, along with positively affecting lipids, blood pressure, cardiovascular events, mortality, and quality of life.Most of the benefits of exercise are realized through acute and long-term improvements in insulin action, accomplished with both aerobic and resistance training, the experts write.For people who already have Type 2 diabetes, the new guidelines recommend at least 150 minutes per week of moderate to vigorous aerobic exercise spread out at least 3 days during the week, with no more than 2 consecutive days between bouts of aerobic activity. These recommendations take into account the needs of those whose diabetes may limit vigorous exercise.Sheri R. Colberg, PhD, writing chair, professor of exercise science at Old Dominion University, adjunct professor of internal medicine at Eastern Virginia Medical School, Norfolk, Virginia, and regular Diabetes In Control contributor, stated that, Most people with Type 2 diabetes do not have sufficient aerobic capacity to undertake sustained vigorous activity for that weekly duration, and they may have orthopedic or other health limitations. For this reason, the ADA [American Diabetes Association] and ACSM [American College of Sports Medicine] call for a regimen of moderate-to-vigorous activity and make no recommendation for a lesser amount of vigorous activity.The panel specifically recommends that such moderate exercise correspond to approximately 40% to 60% of maximal aerobic capacity and states that for most people with Type 2 diabetes, brisk walking is a moderate-intensity exercise.The expert panel also recommends that resistance training be part of the exercise regimen. This should be done at least twice a week -- ideally 3 times a week -- on nonconsecutive days. The panel also recommends that people just beginning to do weight training be supervised by a qualified exercise trainer to ensure optimal benefits to blood glucose control, blood pressure, lipids, and cardiovascular risk and to minimize injury risk.Regular use of a pedometer is also encouraged. In a meta-analysis of 8 randomized controlled trials and 18 observational studies, people who used pedometers increased their physical activity by 27% over baseline. Having a goal, such as taking 10,000 steps per day, was an important predictor of increased physical activity, according to the expert panel.Finally, the new guidelines emphasize that exercise must be done regularly to have continued benefits and should include regular training of varying types.Physicians should prescribe exercise, Dr. Colberg said in a statement. Many physicians appear unwilling or cautious about prescribing exercise to individuals with Type 2 diabetes for a variety of reasons, such as excessive body weight or the presence of health-related complications. However, the majority of people with Type 2 diabetes can exercise safely, as long as certain precautions are taken. The presence of diabetes complications should not be used as an excuse to avoid participation in physical activity.Med Sci Sports Exerc. 2010;2282-2303.

Missing the Target in Diabetes Management

PV Mayer — 18 Jul 2011 06:41:49 EST

Beyond Metformin:When Are Doctors Intensifying DiabetesTreatment?Jul 16, 2011Melanie HundleyType 2 Diabetes Treatment Intensification - by AmbroResearchers look at how long it took doctors to intensify treatment for Type 2 diabetes patients who failed to hit improvement targets on metformin alone.If you were diagnosed with Type 2 diabetes in the last ten years or so, your doctor may have advised a change in diet, monitoring of blood glucose levels, an occasional HbA1c blood test, increased physical activity, prescribing an anti-hyperglycemic oral medication, metformin, and follow-up visits. Treatment methods, of course, vary for many reasons.If your treatment plan was somewhere along these lines, you were probably relieved you were not going to have to start right away with insulin shots, at least, not just yet. But what if the metformin did not work? When would it be time to try something different? Time to step it up a bit?There are many articles and books discussing treatment intensification for Type 2 diabetes which refers to the point at which a patient's treatment is cranked up to the next level when the current treatment is not working. Some recent research has looked at treatment intensification and common care practice.In August 2011 issue of Diabetes, Obesity, and Metabolism, Fu et al will report the results of their recent study of trends in treatment intensification related to Type 2 diabetes patients, specifically, those who fail to hit their improvement targets using metformin monotherapy (monotherapy refers to using only metformin as the diabetes-specific medication in a treatment plan). The patients in their study may have been prescribed additional medications to reduce hypertension and/or cholesterol, but this review is focusing on the metformin-related results primarily.Where Did They Get The Data?The team of collaborators from the Cleveland Clinic and NJ-based Merck affiliates was provided access to electronic medical record data on over 12 million patients from the humongous General Electric (GE) Centricity database.Fu et al write that the GE database contains anonymous HIPPA-compliant clinical data entered by over 9000 medical providers, i.e., doctors, and includes demographic information, vital signs, laboratory orders and results, medication list entries, prescription orders, diagnoses, and medical problems. That's one comprehensive database. During your next office visit, you may notice a GE Centricity logo on the screen as your doctor patiently asks you questions and enters your responses in his computer.The beauty of having this kind of data is that it can be sliced and diced in amazing ways to support medical research. With modern data analytic techniques, researchers can pose seemingly infinite questions and see if the data can support any correlations or conclusions.READ THIS NEXTUsing Oral Medications to Treat Type 2 DiabetesWeight Gain From Diabetes MedicationsPCOS Infertility Help with MetforminWho Was Selected?To be considered for their study, your anonymous health records would have been in the GE database. Then you would have been at least 18 years old, diagnosed with Type 2 diabetes, on metformin as the only diabetes-specific medication for a given period of time, and had at least one Hb1Ac resulting in 7.0% or greater or two fasting blood glucose measurements at or greater than 126 mg/dl, etc. They pinpointed patients who met their criteria between 1997 and 2008, which gave them over a decade of experience for their analysis. That period of time is referenced as the index date in their analytics.Highlights Of Selection CriteriaFu et al's report walks through their data slicing algorithms and highlights what they found. They looked at a population of over 12,000 patients in their study. The average age was 63 years old, and about half were women.The average HbA1c in the group selected was 8.0% but included some over 9%.Only 64% of patients who failed metformin monotherapy according to the study's criteria were progressed to more intensive treatment.Reported ResultsAfter crunching the numbers, the research team made several interesting observations, including:Physicians seemed less inclined to initiate or intensify therapy in patients nearer a lower target HbA1c;The average time patients followed their original metformin treatment plan was 14 months before treatment intensification;There appeared to be some variance in the metformin-only diabetes treatment time and the dosage levels, i.e., patients who never exceeded 1500 mg of metformin had an average wait of 20.0 months before treatment intensification while those on higher dosages (46% in this study were prescribed 1500 mg or more) intensified in an average of about 9 months;Overall, in U.S. clinical practices, treatment intensification has sped up in the more recent years of the past decade, e.g., doctors appear to be waiting less time to abandon metformin alone when test results are not satisfactory. The researchers suggest this indicates an improvement in diabetes care.Reviewer notes that diabetics with uncontrolled or inconsistent test results, more than one medical condition (co-morbidity), or complications may not align with comparison to this review. In order to assess the effectiveness of any treatment and make decisions about intensification, the diabetic patient must be diligent in following doctor's orders, attending follow-up exams, monitoring progress, reporting any concerns, and asking questions.This team suggests more studies can be done for further assessment of care. For more information, the American Diabetes Association publishes standards of medical care in diabetes.Special Thanks to Dr. Alex Z. Fu, Associate Professor, Department of Quantitative Health Sciences, Cleveland Clinic, for sharing additional information to support this review.Other research-related articles by Melanie Hundley include: Diabetes Testing: What Are You Waiting For?, 2011: ADHD Treatments Reviewed; New Research: Autism and Vaccines.Disclaimer: The information and links contained in this article are for educational purposes only and should not be used for diagnosis or to guide treatment without the opinion of a health professional. Any reader who is concerned about his or her health should contact a licensed medical doctor for advice.SourcesAmerican Diabetes Association. (2011, January). Standards of medical care in diabetes. Diabetes Care,Vol. 34, No. Supplement 1, S11-S61. Retrieved July 16, 2011, from organization website. DOI: 10.2337/dc11-S011.Fu, A. Z., Qiu, Y. Y., Davies, M. J., Radican, L. L., & Engel, S. S. (2011). Treatment intensification in patients with type 2 diabetes who failed metformin monotherapy. Diabetes, Obesity & Metabolism, 13(8), 765-769. Retrieved July 14, 2011 from EBSCOhost online database. DOI:10.1111/j.1463-1326.2011.01405.x.Jordan, J. (2010, November 5). The data analytics boom. Forbes.com. Retrieved July 16, 2011, from corporate website.Lab Tests Online. (2011, June 17). Glucose. Retrieved July 16, 2011, from corporate website.National Center for Biotechnology Information. (2011, May 16). Comparing newer drugs for diabetes including combination drugs. Retrieved July 16, 2011, from PubMed Health online database.National Center for Biotechnology Information. (2010, June). Comparison of ge centricity electronic medical record database and national ambulatory medical care survey findings on the prevalence of major conditions in the united states Popular Health Management, 13(30), 139-50. Retrieved July 16, 2011, from PubMed Health online database.National Center for Biotechnology Information. (2011, April 15). Metformin. Retrieved July 16, 2011, from PubMed Health online database.National Center for Biotechnology Information. (2010, May 10). Type 2 Diabetes. Retrieved July 16, 2011, from PubMed Health online databaseU.S. National Library of Medicine. (April 2011). HbA1c. Retrieved July 1, 2011, from Medline Plus online database.Read more at Suite101: Beyond Metformin:When Are Doctors Intensifying DiabetesTreatment? | Suite101.com http://www.suite101.com/content/beyond-metforminwhen-are-doctors-intensifying-diabetestreatment-a379967#ixzz1SSLb0Oby

Walk Aversion in Diabetics?

PV Mayer — 18 Jul 2011 05:33:50 EST

Why Do Patients with Diabetes Walk Less?Physical activity is a cornerstone of treatment for diabetes, yet people with diabetes perform less moderate and vigorous physical activity (MVPA) than people without diabetes....Diabetes-specific barriers to physical activity are a possible explanation for lower MVPA in patients with diabetes. Some barriers that have been identified are fear of hypoglycemia, the presence of bad feet due to diabetes, and an unwillingness to exercise in the presence of people who do not have type 2 diabetes. Other barriers include lack of social support, lack of knowledge of the types of exercise to perform, health problems, pain/difficulty taking part in exercise, lack of local exercise facilities, and aversion to exercising in poor weather. Regular walking activity is the preferred activity of people with diabetes. The study compares adults' barriers to physical activity by diabetes status in a rural, population sample.Walking is a preferred form of activity in diabetes, but people with diabetes walk less than people without diabetes, often citing fear of injury, according to the results of a study.In contrast, whether differences in walking activity exist has been understudied. Diabetes-specific barriers to physical activity are one possible explanation for lower MVPA in diabetes, the authors write. We hypothesized that people with diabetes would perform less walking and combined MVPA and would be less likely to anticipate increasing physical activity if barriers were theoretically absent compared with people without diabetes.From 2002 to 2004, 1848 randomly selected adult residents of rural Colorado were surveyed by telephone regarding their weekly duration of walking and MVPA. They were also asked about their likelihood of increasing their physical activity if each of 7 barriers was theoretically removed. Odds ratios (ORs) for persons with vs. without diabetes were adjusted for age, sex, body mass index (BMI), and ethnicity. Less active persons were defined as those who reported less than 150 minutes of weekly MVPA, and more active persons were defined as those who reported 150 minutes or more of weekly MVPA.Compared with persons without diabetes, those with diabetes (n = 129) had lower odds of walking and MVPA for 10 or more vs. less than 10 minutes/week (walking-adjusted OR, 0.62; 95% confidence interval [CI], 0.40 - 0.95; MVPA-adjusted OR, 0.60; 95% CI, 0.36 - 0.99).Fear of injury was reported to be a barrier to physical activity more often by respondents with diabetes than by respondents without diabetes (56% vs. 39%; P = .0002). However, adjustment for age and BMI attenuated this association (OR, 1.36; 95% CI, 0.93 - 1.99).Although walking is a preferred form of activity in diabetes, people with diabetes walk less than people without diabetes, the study authors write. Reducing fear of injury may potentially increase physical activity for people with diabetes, particularly in older and more overweight individuals.Further research is needed to identify and overcome physical activity barriers for people with diabetes, the study authors conclude. From a public health perspective, we need to identify key modifiable physical activity barriers that are related to physical activity levels in larger studies that are representative of the overall population with diabetes. The identification of key modifiable barriers should guide health policy decisions and the design of future behavioral intervention trials to increase physical activity for people with diabetes.Diabetes Care. Published online June 23, 2011

More About Osteomyelitis by the Master, Dr. Robert Frykberg

PV Mayer — 13 Jul 2011 12:24:01 EST

Robert Frykberg, DPM, MPHPRESENT Editor, Diabetic Limb Salvage Osteomyelitis � Now What?I n our last Foot Notes, we discussed one of the most vexing of problems in the diabetic foot - that of making the diagnosis of osteomyelitis. Vexing because this infection of bone is often present underlying deep foot ulcers, those of long duration, or those with frequent recurrences. To this date, there is no international consensus on what constitutes the best diagnostic method or modality, although bone culture and histopathology have long been considered to be the gold standard. More likely than not, the diagnosis should probably be made by a composite of clinical and imaging findings, such as positive probe test and x-ray changes or deep infected ulcer with exposed capsule and positive bone/indium scans. Most importantly, this common complication of diabetic foot ulcers (DFU) should be looked for when ulcers do not respond to standard therapies as previously discussed in prior Foot Notes eZines. Once the diagnosis has been established, the real conundrum (some would say controversy) begins.Is Osteomyelitis a Surgical or a Medical Disease? In the USA, for instance, osteomyelitis has long been considered a surgical disease - one that required primarily surgical treatment with adjunctive prolonged antimicrobial therapy (usually parenteral). This has been taught in Medical School and surgical training programs for years. Unfortunately, this approach has been based on a customary treatment that likely began in the pre-antibiotic era. There is little data to absolutely support the necessity for surgery � including the total removal of the infected bone. However, even in general medical circles, there is a general consensus that debridement of dead bone or sequestra is necessary. Nonetheless, how much bone needs to be removed, when it needs to be removed, and how long antimicrobial therapy needs to be continued, remain undetermined.The Surgeons Have It

Part 3 of CHCH Maria Hayes' Report on Wound Care

PV Mayer — 11 Jul 2011 07:01:24 EST

It's tough to bring any new product to market.And when it's a healthcare product, requiring ministry approval, it's definitely a challenge.Maria Hayes explains in the final segment of her Open Wounds series. Enjoy Maria's last installment on the state of wound care in Hamilton.http://www.chch.com/index.php/home/item/4443-introducing-new-wound-care-products-a-struggle

Part 2 of Wound Treatment in Hamilton

PV Mayer — 06 Jul 2011 06:57:28 EST

In part 2 of her series on wound care, CHCH. reporter, Maria Hayes, explores further the etiology of diabetic foot wounds and some of the exciting and innovative new advanced treatment modalities that can help heel these devastating wounds. Enjoy. http://www.chch.com/index.php/home/item/4420-therapy-for-open-wounds

Diabetes is a DEADLY DISEASE.

PV Mayer — 05 Jul 2011 09:06:41 EST

Diabetes kills 1 person every 8 seconds, 4 million a year: International Diabetes FederationSome postings today from our friends at the IDF, including Jean Claude Mbanya:#Diabetes kills: 1 person every 8 seconds, 4 million people a year. Find out how to act on diabetes. Now. worlddiabetesday.org Today's Independent (UK) features a #diabetes special insert with a welcome from our President Jean Claude Mbanya http://t.co/nFKe641

Dr. Mayer Speaks to CHCH Health Reporter, Maria Hayes about Wounds in Hamilton, Ontario.

PV Mayer — 05 Jul 2011 05:31:35 EST

Local Hamilton CHCH TV reporter, Maria Hayes, talks to Dr Perry Mayer about the devastating effects of diabetic foot wounds in the first of a brilliant 3 part piece on on the state of wound care in Ontario. Enjoy.http://www.chch.com/index.php/home/item/4395-open-wounds-tricky-to-treat

Tissue Heats Up Before it Breaks Down. Dr. Paul Brand

PV Mayer — 12 Jun 2011 01:27:32 EST

Heat sensitive bandage could combat infection 6 June 2011Fibres used in the bandage can respond to changes in temperature. Image courtesy: Louise van der Werff/CSIROA bandage that warns of infection by changing colour has been developed by Monash University and CSIRO.Lead inventor and Monash PhD student, Louise van der Werff said the bandage could lead to speedier and more effective treatments for chronic wounds, such as leg ulcers and bedsores.The bandage works by changing colour according to temperature, Ms van der Werff said.Changes in temperature can indicate inflammation or suggest problems with blood supply, which can lead to infection. The bandage will help patients and clinicians with early detection, allowing them to treat any complications before they become serious.The cost of treating chronic wounds in Australia is estimated to be around $500 million each year. Prolonged, or chronic inflammation can delay and in some cases jeopardise the healing process.If problems are not quickly identified and treated, wounds can persist for months or years, resulting in a major reduction in quality of life. Not only that, the average cost of treatment is over $25,000 per wound, Ms van der Werff said.So far, the researchers have successfully developed the temperature sensitive textile, with the next step being to turn it into a full fledged bandage that will be commercially produced.The fabric weve created is sensitive to changes of less than half a degree Celsius. Patients and clinicians will be able to match the colour of the fibres with a calibrated chart that indicates the health of the wound, Ms van der Werff said.Currently clinicians use electronic equipment to determine temperatures across the wound and surrounding tissue. We expect the bandage will deliver significant cost savings.Ms van der Werff is one of 16 early-career scientists recently chosen to present their research to the public through Fresh Science, a national program sponsored by the Australian Government. As part of Fresh Science, Ms van der Werff will present her research during the next week at AMPs Amplify Festival in Sydney, over dinner with Australias Chief Scientist in Melbourne, and to school students in Melbourne and Bendigo.

The Cost of Diabetic Foot Disease: There's an app for that.

PV Mayer — 10 Jun 2011 10:37:42 EST

APodC Diabetic Foot Toll CalculatorReportEmailWritten by aiolarte on Jun-7-11 12:07amFrom: podiatry-arena.comPress Release:SILENT TOLL OF DIABETES EXPOSEDQuote:The devastating effect diabetes has on the lives, limbs and hip pockets of many Australians has now been fully exposed for the first time. The Australasian Podiatry Council (APodC) has created the diabetic foot disease toll calculator, which shows the effect of diabetes on foot health in terms of hospital bed days, lower extremity amputations, deaths and costs in real time. The left hand side of the calculator shows the consequences if the current system of diabetic foot health management in Australia is maintained. The right hand side shows how the effects can be reduced with optimal foot health care. APodC President, Andrew Schox says the calculator is a sobering reminder of the reality facing many Australians.‘The fact is that improper foot health care is forcing many Australians with diabetes into our hospitals, where they may have a lower limb amputation or even die.’ Mr Schox said.‘It’s a ludicrous situation when you realise that four out of five of these amputations may have been avoided if the patient had been given optimal foot health management’, Mr Schox continued.‘At the moment patients with diabetes are only entitled to a maximum of 5 Medicare funded appointments with a podiatrist every year. In fact, many patients need around 12 appointments to reduce their leg wounds to avoid hospitalisation’. ‘The recent Federal Budget was billed as a cost-cutting budget, and yet it contained nothing about boosting the number of Medicare-funded podiatry visits for patients with diabetes.’‘It would have been an excellent way to save money in the federal health budget. The research and this calculator show us that by spending more money on podiatry and foot care we can actually save the Australian taxpayer over $300 million each year. For example, a dozen Medicare-funded podiatry appointments for patients with diabetes costs a few hundred dollars, while lower limb amputations can cost the health system anywhere up to $100,000 per patient’.‘It really is just simple maths – and in reality, the calculator shows not only the number of largely avoidable hospital admissions, but also the millions of tax-payer dollars that could have been saved.’ Mr Schox concluded.To view the calculator, please go to this link: www.apodc.com.au

Food for Thought

PV Mayer — 03 Jun 2011 04:12:55 EST

A great article from the folks at Diabetes-in-Control.In 1970, the group Five Man Electrical Band released the hit single, Signs, and in it there is a line, Do This, Dont Do That, Cant You Read The Sign? It seems that when it comes to food choices for diabetes patients the line should be, Eat This, Dont Eat That, Cant you Read the Sign? as every day someone else has a new miracle food to cure or prevent diabetes. Most of these health claims are suspect at best and often they are just a way for someone to make a lot of money. In this month's special edition we have looked over scores of articles, reports and health claims, to find the right things to eat and the right way to eat them. We have everything from almonds to zucchini -- and everything in between -- for you to share with your patients and unlike everyone else we let you know where the research came from and what the real effects might be.David Joffe Editor-in-chiefNutsAcute and Second-meal Effects of Almonds in Prediabetes Inclusion of almonds in the breakfast meal decreased blood glucose concentrations� [ Full Story ]Almonds Help Reduce Risk of Type 2 Diabetes and Cardiovascular Disease Incorporating almonds into your diet can help treat and possibly prevent Type 2 diabetes, as well as cardiovascular disease� [ Full Story ]FiberMore Fiber Reduces Cardiovascular and All-Cause Death Getting lots of dietary fiber appears to reduce the risk of dying -- particularly from cardiovascular, infectious, or respiratory diseases.� [ Full Story ]Consumption of Diets High in Prebiotic Fiber or Protein during Growth Influences the Response to a High Fat and Sucrose Diet in Adulthood The data suggest that while a long-term diet high in protein predisposes to an obese phenotype when rats are given a high energy diet in adulthood, consumption of a high fiber diet during growth may provide some protection.� [ Full Story ]GrainsLess Refined, More Whole Grains Linked to Lower Body Fat US researchers found that people who every day eat several servings of whole grains and limit intake of refined grains have less visceral adipose tissue or VAT, a type of body fat believed to trigger cardiovascular disease and Type 2 diabetes.� [ Full Story ]White Rice Verses Brown Rice and Diabetes Risk Consuming more white rice appears to be associated with a higher risk for developing Type 2 diabetes, whereas consuming more brown rice may be associated with a lower risk for the disease.� [ Full Story ]Whole Grain, Bran Reduces CV Mortality in Women with Type 2 Diabetes Women with Type 2 diabetes who ate more than 9 g of bran per day had a 35% lower risk for death from cardiovascular disease and a 28% lower risk for all-cause mortality compared with women who ate less bran, according to new study findings.� [ Full Story ]Green Leafy VegetablesNitrates in Spinach Counteract Components of Metabolic Syndrome Nitrates reduce oxygen consumption during physical exercise; however, they are also of potential significance to diseases involving mitochondrial dysfunction, such as diabetes and cardiovascular disease.� [ Full Story ]Green Leafy Vegetables Cuts The Risk of Diabetes by 14% A British meta-analysis found that increasing the daily intake of green leafy vegetables can reduce the risk of Type 2 diabetes� [ Full Story ]VitaminsDiabetes Risk Falls as Magnesium Intake Increases Getting enough magnesium in your diet could help prevent diabetes, a new study suggests. Consuming 200 milligrams of magnesium for every 1,000 calories reduces risk of diabetes by 47%� [ Full Story ]Vitamin K Linked to Lower Diabetes Risk People who get plenty of vitamin K from food may have a lower risk of developing Type 2 diabetes than those who get less of the vitamin, a new study suggests.� [ Full Story ]Antioxidants Increase Insulin Sensitivity A diet high in antioxidants may help increase insulin sensitivity and enhance the effects of metformin, according to a small study.� [ Full Story ]CoffeeWhy Coffee May Help Protect against Diabetes Coffee can give you a jump-start to the day but numerous studies have shown that it also may be protective against Type 2 diabetes� [ Full Story ]Coffee Reduces Risk of Diabetes -- One More Study That cup of joe may be doing more than keeping you awake -- it also may be reducing your risk of developing Type 2 diabetes.� [ Full Story ]VinegarVinegar Reduces Postprandial Glycemia Vinegar, when taken regularly, can help manage diabetes, moderate food cravings and increase the body's absorption of calcium resulting to healthier bones.� [ Full Story ]DairyWhole-Fat Milk and Cheese Can Lower Diabetes Risk The incidence of Type 2 diabetes declined significantly as levels of a fatty acid found in whole-fat dairy products increased� [ Full Story ]Spices and OilsCinnamon for Diabetes: It Helps � a Little There may be no harm in adding cinnamon to your diabetes regimen, but does it really help?� [ Full Story ]Why Fish Oils Can Improve Diabetes Control Researchers at the University of California, San Diego School of Medicine have identified the molecular mechanism that makes omega-3 fatty acids so effective in reducing chronic inflammation and insulin resistance� [ Full Story ]Moderate Wine/Alcohol and GrapesEASD: Moderate Wine Drinking Lowers Fasting Glucose in Type 2 Diabetes A glass of merlot or perhaps sauvignon blanc with dinner may offer modest benefits for patients with Type 2 diabetes, said researchers.� [ Full Story ]Moderate Drinking Linked to 44%-65% Lower Diabetes Risk Adults who have a drink or two per day may have a lower diabetes risk than teetotalers and the link does not appear to be explained by� [ Full Story ]Grapes Reduce Risk Factors for Heart Disease, Diabetes Findings show grape consumption lowered blood pressure, improved heart function and reduced other risk factors for heart disease and metabolic syndrome� [ Full Story ]Moderate Drinking in Women Linked to Less Weight Gain Lu Wang, MD, PhD, from Brigham and Women's Hospital in Boston, MA, and colleagues write, The obesity epidemic is a major health problem in the United States� [ Full Story ]FatsBacon at Breakfast Healthier than a Bagel The age-old maxim Eat breakfast like a king, lunch like a prince and dinner like a pauper may in fact be the best advice to follow to prevent metabolic syndrome, according to a new study� [ Full Story ]Follow this link to download a quick reference pdf of all of the benefits and dosages for Foods Which May Help Reduce Diabetes and Pre-diabetes Risk.