A large new study has found that 98% of those diabetic patients with foot ulcers had neuropathy signs. Kahn et al assessed 2052 diabetic patients with and without diabetic foot ulcers (DFU). The leading risk factor by far in the DFU group was neuropathy followed by obesity, waist circumference and dyslipidemia. Interestingly, over 17% of the total study population developed DFU. These results confirm the primacy of neuropathy among risk factors precipitating DFUs and their attendant complications.
CMS has recently updated its MIPS (Merit-based Incentive Payment System) Quality Measures. Measure #126 continues to be retained for performance of neurological exams on the feet of diabetic patients. As Measure Steward for this indicator, APMA (American Podiatric Medical Association) has done an excellent job creating a flowchart on implementation. Consistent with prior years, evaluation includes at least annual testing with the 10 gm monofilament plus one of the following:
Vibration Test Using 128 Hz Tuning Fork Pinprick Sensation Ankle Reflexes Vibration Perception Threshold
O’Brien Medical is gratified to see that CMS has included vibration testing in two of its four recommended adjunct tests. This decision also reflects current ADA (American Diabetes Association) recommendations.
A new study by Geiss from Diabetes Carereveals a disturbing trend toward increasing rates of lower extremity amputations in young (18-44 y/o) and middle-aged (45-64 y/o) diabetic patients. This comes after a two-decade long decline in amputation rates in all diabetic patients. The study noted this upward spike in data collected from 2010-2015 in the US. As to the potential causes for this finding, the authors suggest a “fundamental failure” in amputation prevention. They go on to note:
“Many amputations may be avoided through attention to self- and clinical care practices to manage risk factors, including glycemic control and cardiovascular disease risk factors, and through early detection and appropriate treatment of foot ulcers . Increasing rates of NLEAs (non-traumatic lower extremity amputations), particularly minor amputations, suggest either early prevention practices (e.g., self management education, appropriate footwear, foot exams, and identification of high-risk feet) might not be optimally performed to prevent foot ulcers and/or there may be delays in timely treatment of ulcers.”
Indeed, this systemic failure to prevent these tragic events is a recurring frustration well known to those treating diabetic patients. An aggressive team-based approach incorporating primary care, podiatry, diabetes educators, vascular surgeons, nutritionists and wound care specialists is required in addition to active and willing patient participation. Additionally, the importance of aggressive early prevention cannot be over emphasized. This is germane in the diabetic foot with regard to early detection of diabetic neuropathy. The graphic below illustrates the concept well. In essence, the earlier neuropathy is diagnosed, the earlier prevention can be implemented to avoid amputations. A worthy goal for patients and providers alike.
Earlier diagnosis of neuropathy indicated by the yellow arrow could help avoid amputations through earlier preventative intervention.
In contrast, current guidelines focus on identifying Loss of Protective Sensation (LOPS) as a trigger for prevention.
The company is gratified to announce successful registration of the ETF128 with the Italian Ministry of Health, clearing the way for entry into the Italian market. This is an important milestone as it is represents the company’s first expansion into the EU. The company plans to sell its products through an authorized representative per Ministry of Health guidelines. “We are excited to embark on this venture into the Italian market.” said CEO, Todd O’Brien. ” Fortunately, we have found an excellent corporate partner to work with as we move forward. I think we have the opportunity to do something very innovative together.”
More details on this new market opportunity will be available in future posts.
The company is pleased to announce recent seed grant approval from the Maine Technology Institute (MTI). The award will be used to develop a proof-of-concept prototype designed to extend the feature set of the company’s core product, the ETF. Much of the work will be done in collaboration with the University of Maine’s Department of Chemical and Biomedical Engineering. Funding will also cover patent filing on the novel prototype.”We’re excited to work with MTI and UMaine to push the boundaries of clinical care diagnostics.” said company CEO, Todd O’Brien. ” The extended capabilities we’re developing for the ETF will provide a unique approach for assessing neuropathy in a point-of-care setting”.