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.
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