CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds
Sponsored by DEBx Medical B.V.
About this trial
Last updated 7 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Started 7 months ago
What is this trial about?
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.
