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

NCT07360418 | Recruiting

• 1 other identifier: Pro00084454
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CAMPX; CAMP; Foot Ulcer; diabetic foot ulcer

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Secondary Outcomes (1)

• Virtual Long-Term Follow Up

  52 weeks

Study Arms (1)

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.

Other: Blue Drop Foot Scanner

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.

OneStep Foot Scanner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Applied Biologics, LLC: lead
• Serena Group: collaborator

Study Sites (1)

Detroit Foot and Ankle

Clinton Township, Michigan, 48038, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Ulcer; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foot Diseases

Central Study Contacts

Bennett Sarver

CONTACT

1-833-865-6300; info@serenagroups.com

Thomas Serena, MD

CONTACT

1-833-865-6300; info@serenagroups.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 22, 2026
• Study Start: October 16, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)