CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds

NCT ID: NCT07206862

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-02-28

Brief 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.

Detailed Description

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.

Conditions

Diabetic Foot Ulcer (DFU); Diabetic Foot Ulcer Treatment; Diabetic Foot Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DEBRICHEM® + conventional wound care

Single topical application of DEBRICHEM® (desiccant gel for chemical debridement) at inclusion, then standard wound dressings and care.

Group Type: EXPERIMENTAL

DEBRICHEM®

Intervention Type: DEVICE

Single topical application of DEBRICHEM® (desiccant gel for chemical debridement) at inclusion, then standard wound dressings and care.

Conventional wound care only

Mechanical debridement and wound dressing per standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DEBRICHEM®

Single topical application of DEBRICHEM® (desiccant gel for chemical debridement) at inclusion, then standard wound dressings and care.

Intervention Type: DEVICE

Other Intervention Names

Topical Desiccating Agent; TDA; DEBRICHEM

Eligibility Criteria

Inclusion Criteria

• Adults ≥18 years.
• Diabetic foot ulcer (toe, dorsal, plantar, or lateral foot) persisting ≥4 weeks without improvement.
• Requires debridement.
• Wound size 0.5-10 cm².
• Texas classification 0-IIC (controlled neuro-ischemic ulcers, localized infection only).
• HbA1c ≤10% in last 3 months. Peripheral arterial disease controlled, no critical limb ischemia (toe pressure >50 mmHg OR ankle pressure >70 mmHg OR TcPO2 >30 mmHg).

Exclusion Criteria

• Allergy to DEBRICHEM® components.
• Active malignancy, osteomyelitis, fasciitis, exposed cartilage.
• Revascularization <4 weeks prior.
• Systemic infection.
• Pregnant or breastfeeding women.
• Vulnerable populations under legal protection.
• Participation in another clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DEBx Medical B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ariane Sultan, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Central Contacts

Johannes Snels, MSc

Role: CONTACT

info@debx-medical.com

0031 85 0878096

Bert Quint, PhD

Role: CONTACT

info@debx-medical.com

0031 85 0878096

Other Identifiers

CHEMfoot

Identifier Type: -

Identifier Source: org_study_id