Sensory Insole System Trial Results in Significantly Lower Diabetic Foot Ulcer Recurrence Rates
CALGARY, Alberta, Oct. 23, 2019 /PRNewswire/ -- New research reports when patients with diabetes and a previous history of a healed foot ulcer receive audio-visual alerts of sustained, elevated plantar pressure through a novel, sensory insole system there is a significant reduction in diabetic foot ulcer (DFU) incidence.1 Orpyx Medical Technologies Inc. (Orpyx) announced the results from the study "Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study," which was published in The Lancet Digital Health Journal.
The randomized, controlled, multi-site trial, conducted at Manchester Metropolitan University and Lancashire Teaching Hospital in the U.K., demonstrated a 71% reduction in ulcer incidence in the group receiving audio-visual alerts and off-loading instructions, compared to the control group that did not receive alerts and instructions. In an additional exploratory analysis of patients with good adherence, defined as wearing the sensory insoles for at least 4.5 hours per day, there was an 86% reduction in DFU incidence compared to the control group.1
"These results are meaningful, as they reflect what is actually occurring on the plantar surface of the foot as the patients go about their daily activities," stated Neil Reeves, PhD, study lead and Professor of Musculoskeletal Biomechanics at Manchester Metropolitan University in Manchester, U.K. "Even more importantly, we know education alone is not sufficient to change the behaviour of patients with diabetic peripheral neuropathy (DPN). With this system, the patient can react to the alerts and immediately change their behaviour to relieve high pressures when they occur."
Seventy percent of people with diabetes develop DPN which often leads to a lack of feeling in the feet, DFU formation, and in the most severe cases, amputation.2 Under-managed DPN is the number one cause of non-traumatic lower limb amputation.3 These complications cause enormous physical and psychological stress on the patient and are a huge financial burden on the health care system.
Plantar pressure is considered an early indicator of DFU formation.4 The Orpyx® SI sensory insoles are the first system designed specifically to help mitigate this risk by providing the patient with real-time feedback, enabling them to take immediate action. In addition, the sensory insoles monitor variances in plantar foot temperature which is considered a late-stage indicator for DFU formation, providing an additional warning parameter to help health care providers treat DFUs, which occur in 25% of the diabetic patient population.
View/download the study at: https://www.orpyx.com/clinical-study
1. Abbott CA et al. Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. The Lancet Digital Health. Vol.1 October 2019.
2. The National Institute of Neurological Disorders and Stroke. Peripheral Neuropathy Fact Sheet. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Peripheral-Neuropathy-Fact-Sheet. October 2019.
3. The Foundation for Peripheral Neuropathy. Peripheral Neuropathy Risk Factors and Facts. https://www.foundationforpn.org/what-is-peripheral-neuropathy/types-risk-factors/. October 2019.
4. Armstrong D et al. Diabetic Foot Ulcers and Their Recurrence. New England J of Medicine. June 2017; 376;24.
Media Contact:
Karen Smith
Phone: (210) 823-9604
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Investor Contact:
Breanne Everett, MD
Phone: (403) 472-9949
Email: [email protected]
Related Files
Abbott_Insole System Reduces DFU Recurrence (092619).pdf
Abbott Study Press Release_FINAL (10-22-19).pdf
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