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