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

Applied Biologics

Status: Enrolling

Conditions: Ulcer; Diabetic Foot Ulcers (DFU); Foot Ulcer Chronic; Diabetic Foot Ulcer

Treatments: Other: Blue Drop Foot Scanner

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07360418

Pro00084454

Details and patient eligibility

About

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

Full 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..

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

OneStep Foot Scanner

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.

Treatment:

Other: Blue Drop Foot Scanner