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CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds

NCT07206862 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-10-03

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

DEBRICHEM®

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

Sponsors & Collaborators

  • DEBx Medical B.V.

    lead INDUSTRY

Principal Investigators

  • Ariane Sultan, MD · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-12-23
Completion
2027-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07206862 on ClinicalTrials.gov