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

NCT07360418 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-02-10

No results posted yet for this study

Summary

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

Conditions

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Serena Group

    collaborator OTHER

  • Applied Biologics, LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-16
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07360418 on ClinicalTrials.gov