CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds

Diabetic foot ulcers (DFU) are a severe complication of diabetes, affecting approximately 20-25% of patients during their lifetime and preceding up to 80% of lower-limb amputations. Chronic wounds are often associated with biofilm formation, which sustains inflammation, delays healing, and reduces the efficacy of mechanical debridement and systemic treatments. New approaches targeting biofilm could improve wound outcomes.

DEBRICHEM® is a CE-marked (Class IIb) medical device developed by DEBx Medical B.V. It is a red, semi-fluid desiccant gel that rapidly binds water molecules in biological material, thereby disrupting biofilm and necrotic tissue. The gel is applied topically for 60 seconds and then rinsed with saline, replacing conventional mechanical debridement. Previous case series and observational data suggest DEBRICHEM® may accelerate granulation and wound closure. However, no randomized controlled trial has yet demonstrated its clinical benefit in diabetic foot ulcers.

The CHEMfoot study is a prospective, open-label, randomized controlled trial conducted at six centers in France. Adults with type 1 or type 2 diabetes and chronic foot ulcers (≥4 weeks, 0.5-10 cm², Texas grade 0-IIC) will be randomized 1:1 to:

Intervention arm: single topical application of DEBRICHEM® plus standard wound care.

Control arm: standard wound care alone, including mechanical debridement and appropriate dressings.

The primary endpoint is the proportion of patients with complete wound healing at 20 weeks, defined as 100% re-epithelialization, wound closure, and absence of exudate, confirmed by blinded investigators and an independent adjudication committee reviewing photographs.

Secondary outcomes include:

Complete healing at 8 and 12 weeks.

≥50% wound surface reduction at 4, 8, 12, and 20 weeks. Change in wound size over time. Local infection rates. Pain (Visual Analog Scale) before/after debridement and during dressing changes.

Quality of life (EQ-5D-5L, EQ-VAS) and sleep (Epworth Sleepiness Scale). Healthcare utilization (hospitalizations, antibiotic prescriptions). Usability of DEBRICHEM® by healthcare professionals (System Usability Scale). Safety outcomes include the incidence and type of adverse events (AE/SAE) related to DEBRICHEM®, as well as pain levels at predefined time points after application (immediately, 2 hours, 24 hours).

A total of 242 patients (121 per arm) will be enrolled to provide 80% power to detect a 20% absolute difference in healing rates (60% vs. 40%) at 20 weeks, assuming a 20% dropout rate. Randomization will be stratified by center and wound size (0.5-5 cm² vs. \>5-10 cm²).

The study duration is 12 months (7 months recruitment, 5 months follow-up). Results will provide high-level evidence on whether DEBRICHEM® offers added value to the standard management of chronic diabetic foot ulcers.

• wound healing wk 8 [Срок оценки: week 8]
• wound healing week 12 [Срок оценки: 12 weeks]
• Proportion of patients with ≥50% wound surface reduction [Срок оценки: 20 weeks]
• wound area change [Срок оценки: 20 weeks]
• Incidence of wound infection [Срок оценки: 20 weeks]
• Quality of Iife [Срок оценки: 20 weeks]
• Pain Score [Срок оценки: 20 weeks]
• Sleep quality [Срок оценки: 20 weeks]
• health resources [Срок оценки: 20 weeks]
• treatment usability [Срок оценки: 20 weeks]
• Safety by adverse event monitoring [Срок оценки: 20 weeks]