RECRUITINGOBSERVATIONAL
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
About This Trial
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
Who May Be Eligible (Plain English)
Who May Qualify:
- The potential subject must have participated in the CAMPX trial and achieved complete closure by the 12-week endpoint.
Who Should NOT Join This Trial:
- The potential subject did not participate in the CAMPX trial.
- The potential subject participated in the CAMPX trial and did not achieve complete closure.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
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.
Locations (1)
Detroit Foot and Ankle
Clinton Township, Michigan, United States