Evaluating the Durability of Closure for Diabetic Foot Ulcers Following a Randomized, Controlled, Modified Platform Trial.

ConditionsDiabetic Foot Ulcers (DFU)Foot Ulcer Chronic Ulcer Diabetic Foot Ulcer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorApplied Biologics, LLC

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The potential subject must have participated in the CAMPX trial and achieved complete closure by the 12-week endpoint.

Disqualifiers

The potential subject did not participate in the CAMPX trial.

The potential subject participated in the CAMPX trial and did not achieve complete closure.

Trial population

The study population will be drawn from diabetic subjects who have previously completed the CAMPX trial and achieved complete closure.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Blue Drop Foot Scanner
Other intervention
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.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: OneStep Foot Scanner1 intervention

Trial outcomes

Primary outcomes

Rate of Recurrence

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.

Time frame

52 weeks

Secondary outcomes

Virtual Long-Term Follow Up

To evaluate the effectiveness of virtual clinical trial technology in the conduct of a long-term follow up trial.

Time frame

52 weeks

Sponsors and contacts

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Applied Biologics, LLC

Lead sponsor

Serena Group

Collaborator

Source ClinicalTrials.gov

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