Prevention of Foot Ulcer Recurrence in Individuals Who Are at High-risk for Diabetic Foot Complications Using the Orpyx Sensory Insole System: a Multisite, Randomized, Controlled Trial
Johns Hopkins University
Summary
The primary aim of this study is to demonstrate the impact of the Orpyx® 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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosed Type 1 or 2 diabetes * Clinically diagnosed neuropathy via Neuropathy Monofilament Test (Appendix A) * Qualification as a "high-risk participant," meaning a recent history (\<12 months) of a healed diabetic neuropathic ulceration on the weight-bearing surface of one or both feet (this includes the plantar distal toe surface) * Complete healing of any previous foot ulcers, as defined by complete re-epithelialization of that ulcer which is confirmed by two medical exams that occur at least two weeks apart (screening visit and baseline study visit) * Ability to wa…
Interventions
- DeviceOrpyx Sensory Insole System
The Orpyx Sensory Insoles System uses Orpyx Sensory Technology: a powered limb overload warning technology intended for monitoring physiologic parameters, such as plantar pressure, temperature, motion, and adherence, and providing real-time cues for pressure offloading
Location
- Johns Hopkins HospitalBaltimore, Maryland