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.
Study summary
Prospective long-term follow-up on durability of closure evaluated by photographic and thermal scanning.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Rate of Recurrence — 52 weeks To demonstrate durability of closure (rate of recurrence) of subjects with a closed diabetic foot ulcer during the CAMPX clinical trial comparing subjects treated with Single Layer Amniotic Membrane (SLAM) plus standard of care (SOC) to subjects treated with SOC alone.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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