Clinical Research Directory

CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds

Sponsor: DEBx Medical B.V.

Summary

This multicenter, randomized controlled trial will evaluate the effectiveness and safety of DEBRICHEM®, a topical desiccant gel, when added to standard care for chronic diabetic foot wounds. Chronic diabetic foot ulcers affect up to 25% of people with diabetes and are associated with high risks of infection, hospitalization, amputation, and mortality. Biofilm formation plays a key role in wound chronicity and delayed healing. DEBRICHEM® is designed to chemically debride wounds by removing biofilm in a single topical application, potentially accelerating the healing process. A total of 242 adult patients with chronic diabetic foot ulcers (≥4 weeks, 0.5-10 cm²) will be randomized to receive either conventional wound care plus a single application of DEBRICHEM® or conventional wound care alone. The primary endpoint is the proportion of patients achieving complete wound healing at 20 weeks. Secondary outcomes include wound size reduction, infection rates, pain, quality of life, sleep, healthcare resource use, and safety.

Official title: Clinical Evaluation of the Addition of DEBRICHEM® to the Routine Management of Chronic Diabetic Foot Wounds: an Open-label Randomized Controlled Trial (CHEMfoot Study)

Key Details

Conditions

Interventions