A Study to Evaluate the Safety and Efficacy of a Novel Wound Dressing in Patients With Diabetic Foot Ulcers
Summary: This ongoing Phase 2 randomized, controlled trial (NCT07206862) is assessing the safety and efficacy of a novel wound dressing compared to standard-of-care dressings in adults with chronic diabetic foot ulcers (DFUs) that have persisted for at least 4 weeks despite optimal therapy. Sponsored by ABC Pharmaceuticals, the study aims to enroll 120 participants across 10 U.S. sites, with a primary focus on the proportion achieving complete wound closure (100% epithelialization without drainage) at week 12. Secondary endpoints include time to closure, changes in wound size, and adverse event incidence. Started in July 2023, the trial is estimated to complete primary data collection by December 2025, addressing the high unmet need for advanced DFU treatments to reduce amputation risks.
Key Highlights:
- Eligibility: Adults ≥18 years with Wagner grade 1-2 DFUs (≤10 cm² area, ≥30 days duration); excluded if active infection, poor vascularity, or recent use of growth factors.
- Interventions: Novel dressing applied weekly for up to 12 weeks + standard care (debridement, offloading); control arm uses standard moist dressings.
- Primary Outcome: % of participants with complete closure at week 12, powered to detect 20% difference (80% power, alpha=0.05).
- Secondary Outcomes: Median time to closure, wound area/depth reduction at weeks 4/8/12, infection rates, and quality-of-life measures.
- Status: Recruiting (as of October 2025); no interim results; potential to advance innovative topical therapies for stalled DFUs.
Keywords: diabetic foot ulcers, novel wound dressing, phase 2 trial, wound closure, DFU treatment