The company was please to learn that the ETF128 will be one of the vibration testing methods utilized in an international clinical trial assessing the effects of benfotiamine on patients with diabetic peripheral neuropathy (DPN). This randomized, double-blind, placebo-controlled study will compare benfotiamine 300 mg twice per day to placebo over 12 months. Vibration testing with the ETF will be one of several nerve function tests measuring secondary endpoints. We are looking forward to the outcomes of this well-designed study as benfotiamine is one of the most promising supplements on the horizon for patients with DPN.
Hamilton et al. just published an article in Diabetes Carehighlighting a disturbing trend previously discussed in this blog. In their comprehensive study spanning 24 years, Hamilton et al. compared the incidence of hospitalization in two temporally-distinct cohorts of patients with diabetes with and without diabetic foot ulcers (DFUs). They found the overall incidence of DFU hospitalizations was increased over time. Just as concerning, this incidence was increased in younger patients in the more recent group. This mirrors findings by Geiss et al. who demonstrated a resurgence of Lower Extremity Amputations (LEAs) in middle-aged and younger adults with diabetes. Additionally, this trend toward younger patients experiencing DFUs was noted in a pending publication by Dr. O’Brien evaluating the combined value of the Semmes-Weinstein monofilament and the ETF128 in predicting DFUs. Overall, movement toward earlier diabetes diagnosis with its attendant complications appears to be emerging. Some speculation has tied this tendency to behavioral and lifestyle choices made by younger patients, thus highlighting the need for improved patient education and compliance with preventative care recommendations.
Although the International Federation of Diabetes (IDF) put out these clinical practice guidelines in 2017, we were gratified to see our 2014 ETF Proof-of-Concept study cited on page 19 of the document. We are cited in the section on using a 128 Hz tuning fork to assess diabetic peripheral neuropathy.
A new article written by Prabhakar et al. has demonstrated the utility of timed vibration testing in diagnosing distal sensory polyneuropathy (DSP) due to a variety of conditions. They utilized a 128 Hz tuning fork and a handheld stopwatch to time how long patients could feel the vibrations at the hallux, medial malleolus and tibial tuberosity. They noted sensitivity of 85% for the test. Additionally, they were able to conclude that patients with vibration sense lasting >8 seconds at the hallux were free of DSP. Coincidentally, this correlates well with the new 7 second cutoff for early neuropathy on theupdated ETF.
The ETF was originally conceived as a way of assisting providers and patients in the prevention of diabetic foot complications through improved diagnosis and tracking of diabetic peripheral neuropathy (DPN). With this is mind, the company is pleased to announce our latest product updates. Customer feedback combined with the latest evidenced-based research has resulted in three product improvements.
The vibration output has been adjusted to make the testing time two seconds shorter to diagnose early neuropathy. The old scale cut-off point was at nine seconds, the new one is set at seven seconds.
The vibration output in the 128 Hz Mode at three seconds approximates the vibration level of the typical biothesiometer at the 25 volt level. This is the standard cut-off indicating increased risk of diabetic foot ulceration. Constant Mode is also set to the this level for those who prefer the On/Off Method of testing.
The new labeling on the front of the device (see below) now reflects a risk-based stratification scale that is more clinically relevant. The 25 volt biothesiometer level is denoted at the three second mark on this scale.
These changes will help improve the interpretation of test results and reduce testing time for providers.