Health TrialsbyHealthPanel

CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds

ConditionsDiabetic Foot Ulcer (DFU)Diabetic Foot Ulcer TreatmentDiabetic Foot Wounds
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDEBx Medical B.V.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Allergy to DEBRICHEM® components.

Active malignancy, osteomyelitis, fasciitis, exposed cartilage.

Revascularization <4 weeks prior.

Systemic infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DEBRICHEM®

    Device

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

Treatment groups

242 Participants
are divided into 2 treatment groups
Group A: DEBRICHEM® + conventional wound careExperimental treatment 1 intervention
Group B: Conventional wound care onlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients with complete wound healing at 20 weeks

100% wound surface closure, complete re-epithelialization, and absence of exudate, confirmed by blinded investigator and adjudication committee review of wound photographs.

Time frame
20 weeks

Secondary outcomes

1

wound healing wk 8

Complete wound healing at 8

Time frame
week 8
2

wound healing week 12

Complete wound healing at 12 weeks.

Time frame
12 weeks
3

Proportion of patients with ≥50% wound surface reduction

Proportion of patients with ≥50% wound surface reduction at weeks 4,8,12 and 20

Time frame
20 weeks
4

wound area change

Mean change in wound area (absolute cm² and relative %).

Time frame
20 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DEBx Medical B.V.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: