Status:
NOT_YET_RECRUITING
CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds
Lead Sponsor:
DEBx Medical B.V.
Conditions:
Diabetic Foot Ulcer (DFU)
Diabetic Foot Ulcer Treatment
Eligibility:
All Genders
18+ years
Phase:
NA
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 d...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT07206862
Start Date
October 1 2025
End Date
February 1 2027
Last Update
October 3 2025
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