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NCT05950659 · ClinicalTrials.gov registry record · NA
WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention
A NA study, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 400
- Enrollment target
NCT05950659: Recruiting NA study, sponsored by Johns Hopkins University.
NCT05950659 is a NA study that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 400 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05950659, a NA study, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Orpyx Sensory Insole System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2026-04-22 |
| Est. Completion | 2029-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05950659
The ClinicalTrials.gov registry entry for NCT05950659 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Orpyx Sensory Insole System is the first listed.
NCT05950659 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05950659 about?
NCT05950659 is a clinical study titled "WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention". 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...
What is the current status of trial NCT05950659?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2026-04-22. Estimated completion is 2029-04-01.
What interventions are being tested in trial NCT05950659?
The interventions under investigation include: Orpyx Sensory Insole System (DEVICE).
Who is sponsoring clinical trial NCT05950659?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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