This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

Logo

CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds

Sponsored by DEBx Medical B.V.

About this trial

Last updated 7 months ago

Study ID

CHEMfoot

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Started 7 months ago

What is this trial about?

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.

What are the participation requirements?

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.