First Journal Article Published from SurroSense Rx® Pilot Study II
Calgary, AB, Canada, January 30, 2017 – The Journal of Diabetes Science and Technology published “Smarter Sole Survival: Will Neuropathic Patients at High Risk for Ulceration Use a Smart Insole-Based Foot Protection System?” in the Journal of Diabetes Science and Technology today. The article is the first of several articles expected out of the second pilot study from the University of Arizona Southern Arizona Limb Salvage Alliance (SALSA) clinic under the supervision of Dr. David Armstrong.
In this study, patients with diabetic peripheral neuropathy at a high risk of developing diabetic foot ulcers wore the SurroSense Rx over a three-month period in 2014-2015. Pressure-sensitive inserts in the shoes connect to a smartwatch to provide real-time alerts when dangerous levels of pressure threaten to cause permanent damage to the patient’s tissue, thereby allowing the patient to offload the pressure and avoid the development of pressure ulcers.
Author, Dr. Bijan Najafi, professor of surgery and director of clinical research at the Baylor College of Medicine, noted in the results of this pilot study that a successful response to an alert was defined as pressure offloading occurring within 20 minutes of the alert onset. A total of 17 patients completed this study, with one ulcerative event seen in this group over the study period. Baseline recurrent rates in this patient population are expected to be 20% at 6 months. When provided with alert-based feedback, patients spent 47% less time in “loaded”, or high-risk, pressure states.
The results of this study suggest that smart insoles, together with an alert-based feedback system notifying patients of harmful plantar pressures, are perceived to be effective and acceptable by high risk diabetic patients, and could enhance adherence to prescribed footwear. Specifically, this study suggests that users who receive at least one alert per two hours could enhance adherence to footwear over time, respond better to alert-based feedback, and better perceive the benefit of such a technology-based intervention.
“We’re elated to see the first of what we hope to be many publications from some very important work on the part of Dr. David Armstrong, Dr. Bijan Najafi, and the rest of the SALSA team. It is promising to see such positive patient-reported outcomes from wearing the SurroSense Rx.” said Dr. Breanne Everett, CEO and co-founder of Orpyx Medical Technologies Inc.
About Southern Arizona Limb Salvage Alliance (SALSA)
The Southern Arizona Limb Salvage Alliance (SALSA) is a collaborative clinical and research alliance dedicated to advancing care of the diabetic foot and preventing amputations in North America and worldwide.
About Orpyx Medical Technologies Inc.
Orpyx Medical Technologies Inc. (“Orpyx”) is a wearable pressure sensor technology company focused on medical applications. Orpyx’s primary intention is to address the world’s growing epidemic of diabetes and its associated complications, most notably, peripheral neuropathy, which leads to lack of circulation, numbness, or loss of protective sensation, in the feet. This problem leads to the development of foot ulcers which can ultimately lead to amputation and death infection and ulcers in the feet, also known as peripheral neuropathy. Additionally, this problem affects upwards of 60% of diabetics over the course of their disease and costs the North American health care system over $16.4 billion annually.
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