NCT07360418

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Applied Biologics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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..

Conditions

• Diabetic Foot Ulcers (DFU)
• Foot Ulcer Chronic
• Ulcer
• Diabetic Foot Ulcer

Interventions

Type	Name	Description
OTHER	Blue Drop Foot Scanner	Subjects 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.

Timeline

• Start date: 2025-10-16
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2026-01-22
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States