Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial.
Part of paid clinical trials in Clinton Township, Michigan.
- Sponsor
- Applied Biologics, LLC
- Study ID
- NCT07360418
- Status
- Recruiting
Conditions
- Diabetic Foot Ulcer
- Diabetic Foot Ulcers (DFU)
- Foot Ulcer Chronic
- Ulcer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Blue Drop Foot Scanner — OTHERSubjects with eligible wound will receive a BlueDrop® OneStep Foot Scanner™. They are instructed to step on the scale each morning. The Bluetooth technology transmits a photograph and thermal image to the central monitoring nurse at BlueDrop®. All information transmitted is compliant with HIPPA regulations. Subjects that are unable to use the scale will receive a phone call at months 3,6, 9 and 12 months to determine if the foot has remained closed.
Study Details
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
Key Dates
- Start date
- Oct 16, 2025
- Status verified
- Feb 2026
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2027
Study Design
- Enrollment
- 50 participants (estimated)
Arms
- Arm: OneStep Foot ScannerThis study is a follow-up durability trial from the CAMPX randomized controlled clinical trial. Only subjects who achieved complete closure at 12 weeks in the CAMPX trial will be evaluated. After signing the IRB-approved informed consent form, the subject will receive instruction on the BlueDrop® OneStep Foot Scanner™. In addition, written instructions on use will be provided. Subjects that are unable to use the scale will be asked to answer a questionnaire at 3, 6, 9, and 12 months after signing the consent form.
Primary Outcome Measure
Rate of Recurrence [ Time Frame: 52 weeks ]
Central Contacts
- Bennett Sarver1-833-865-6300
- Thomas Serena, MD1-833-865-6300
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Detroit Foot and Ankle | Clinton Township | Michigan | 48038 | Lina Barman |
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