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
Applied Biologics, LLC
50 participants
Oct 16, 2025
OBSERVATIONAL
Conditions
Summary
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
Eligibility
Inclusion Criteria1
- The potential subject must have participated in the CAMPX trial and achieved complete closure by the 12-week endpoint.
Exclusion Criteria2
- The potential subject did not participate in the CAMPX trial.
- The potential subject participated in the CAMPX trial and did not achieve complete closure.
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Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07360418