Diabetes Clinical Trial
Official title:
Prevention of Foot Ulcer Recurrence in Individuals Who Are at High-risk for Diabetic Foot Complications Using the Orpyx SI Sensory Insole System: a Multisite, Randomized, Controlled Trial
The primary aim of this study is to demonstrate the impact of the Orpyx® SI Sensory Insoles (Orpyx Medical Technologies Inc., Calgary AB, Canada) ("Orpyx" or "the Company") as an adjunct to the standard of care (SOC), as compared to SOC alone, on reducing plantar ulceration incidence in individuals who are at risk for developing diabetic foot complications. The secondary aims of this study are to evaluate participant quality of life, participant engagement, and economic impact, including cost-effectiveness and cost-utility. The study will also use the unique data set collected (plantar pressure, temperature, step count, movement and adherence feedback) to identify foot-loading histories that either lead to or prevent the development of ulceration in the diabetic foot.
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