NCT07360418Recruiting

Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial.

Applied Biologics, LLC

Start Date

10/16/2025

Completion Date

10/1/2027

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..

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

OTHER

Blue Drop Foot Scanner

Interested in This Trial?

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Conditions

Diabetic Foot Ulcers (DFU)Foot Ulcer ChronicUlcerDiabetic Foot Ulcer

Locations

Detroit Foot and Ankle

Clinton Township, Michigan 48038

United States