A Prospective Multicenter Study Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial

What this Trial Is About

This research aims to evaluate the long-term durability of healing for diabetic foot ulcers in participants who previously took part in the CAMPX randomized controlled clinical trial and achieved complete ulcer closure by 12 weeks. The study focuses on monitoring the rate of ulcer recurrence over a 52-week period using photographic and thermal imaging methods. It is an observational follow-up study sponsored by Applied Biologics, LLC. Participants who completed the CAMPX trial with healed ulcers will receive the BlueDropAE OneStep Foot ScannerTRADE, a device that captures daily photographs and thermal images of their feet. Instructions for using the scanner will be provided, along with written guidance. For those unable to use the scanner, researchers will collect information through phone questionnaires at 3, 6, 9, and 12 months after consent. During the study, participants will be asked to use the foot scanner each morning, which transmits data securely to a central nurse for monitoring. Those not using the device will provide status updates via phone. Researchers will assess the rate of ulcer recurrence over 52 weeks and conduct virtual long-term follow-up to understand healing durability. The total participation time is up to one year following consent.

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