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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.

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

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.

Study details
    Diabetic Foot Ulcers (DFU)
    Foot Ulcer Chronic
    Ulcer
    Diabetic Foot Ulcer

NCT07360418

Applied Biologics, LLC

1 February 2026

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