A Prospective Multicenter Study Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Applied Biologics, LLC
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Rate of Recurrence
Study Overview
Brief Summary
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
Detailed Description
This 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..
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The potential subject must have participated in the CAMPX trial and achieved complete closure by the 12-week endpoint.
Exclusion Criteria
- •The potential subject did not participate in the CAMPX trial.
- •The potential subject participated in the CAMPX trial and did not achieve complete closure.
Arms & Interventions
OneStep Foot Scanner
This 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.
Intervention: Blue Drop Foot Scanner (Other)
Outcomes
Primary Outcomes
Rate of Recurrence
Time Frame: 52 weeks
To demonstrate durability of closure (rate of recurrence) of subjects with a closed diabetic foot ulcer during the CAMPX clinical trial comparing subjects treated with Single Layer Amniotic Membrane (SLAM) plus standard of care (SOC) to subjects treated with SOC alone.
Secondary Outcomes
- Virtual Long-Term Follow Up(52 weeks)