WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention
400 participantsStarted 2025-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed Type 1 or 2 diabetes
* Clinically diagnosed neuropathy via Neuropathy Monofilament Test
* 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 (V0 and V1)
* Ability to walk independently (without use of wheelchair) for 30 steps. Use of a walker or cane is acceptable as long as the participant can walk for at least 30 steps.
* Aged \>18 years
* Ability to understand all study requirements and have a life expectancy greater than the study duration
* Vascular assessment (i.e., ABI, segmental pressure) that demonstrates the participant has adequate lower extremity perfusion
* Subject is willing and able to maintain the required offloading (as applicable for the location of the healed ulcer)
* Subject is willing and able to wear the Orpyx Sensory Insoles during ambulatory activity and at home during waking hours, and for a minimum of 5 hours per day
* Compatibility of the device with the participant's footwear
* Most recent HbA1c level of \< 12.0% (in the last 12 months)
* Amputations, if present, are compatible with the use of insoles
Exclusion Criteria:
* Active ulcer or presence of other open chro…