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