WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention

Recruiting N/A Interventional Study
Diabetes Peripheral Neuropathy Diabetic Foot Diabetic Foot Ulcer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
400 (estimated)
Sponsor
Johns Hopkins University · Other
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About This Trial
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 ev…
Trial Locations
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Eligibility Criteria
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 …
Contacts

Emily Bray

+1 (855) 996-7799

emily.bray@orpyx.com

CONTACT