NCT07206862

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 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Oct 2025Feb 2027

First Submitted

Initial submission to the registry

September 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

October 3, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

September 25, 2025

Last Update Submit

October 1, 2025

Conditions

Diabetic Foot Ulcer (DFU)Diabetic Foot Ulcer TreatmentDiabetic Foot Wounds

Keywords

chemical debridementDEBRICHEMtopical desiccating agentTDADFUdiabetic foot ulcer

Outcome Measures

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.

    20 weeks

Secondary Outcomes (11)

  • wound healing wk 8

    week 8

  • wound healing week 12

    12 weeks

  • Proportion of patients with ≥50% wound surface reduction

    20 weeks

  • wound area change

    20 weeks

  • Incidence of wound infection

    20 weeks

  • +6 more secondary outcomes

Study Arms (2)

DEBRICHEM® + conventional wound care

EXPERIMENTAL

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

Device: DEBRICHEM®

Conventional wound care only

NO INTERVENTION

Mechanical debridement and wound dressing per standard of care

Interventions

DEBRICHEM®DEVICE

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

Also known as: Topical Desiccating Agent, TDA, DEBRICHEM
DEBRICHEM® + conventional wound care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Ariane Sultan, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Snels, MSc

CONTACT

0031 85 0878096info@debx-medical.com

Bert Quint, PhD

CONTACT

0031 85 0878096info@debx-medical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Interventional
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2025

First Posted

October 3, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

December 23, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

October 3, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share