Phase IIIA Study of ELU42 Topical Spray for Treating Wagner Grade 1-2 Diabetic Foot Ulcers in Adults

What this Trial Is About

Researchers are evaluating ELU42, a topical small molecule combining a tankyrase inhibitor with a special hyaluronic acid, to study its safety and early effects on chronic diabetic foot ulcers. This Phase IIIA open-label study focuses on adults with Wagner grade 1-2 diabetic foot ulcers lasting between 4 and 52 weeks. The study aims to assess how ELU42 affects wound healing and monitors safety through various health measures. Participants will first receive standard wound care for two weeks, including offloading, dressings, and cleaning. Then, ELU42 topical spray will be applied by trained staff to the ulcer three times a week for six weeks, with up to 18 treatments possible. If the wound heals but later reopens, participants may undergo another six-week treatment course. The study includes weekly visits during treatment and follow-ups for up to six weeks, with additional visits if the wound closes to observe healing over three months. During the study, participants will undergo safety evaluations such as blood tests, heart monitoring, and nutritional assessments. Researchers will measure wound healing by tracking the reduction in ulcer area at weeks 4 and 6 using both manual and automated methods. Secondary assessments include complete wound closure, wound hydration, patient-reported outcomes, and drug level monitoring in some participants. The total participation time includes treatment and follow-up periods up to several months.

Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers