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

Part of paid clinical trials in Clinton Township, Michigan.

Sponsor
Applied Biologics, LLC
Study ID
NCT07360418
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blue Drop Foot Scanner — OTHER
    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 Details

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

Key Dates

Start date
Oct 16, 2025
Status verified
Feb 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: OneStep Foot Scanner
    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.

Primary Outcome Measure

Rate of Recurrence [ Time Frame: 52 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Detroit Foot and AnkleClinton TownshipMichigan48038
Lina Barman

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