Diabetic Foot Ulcer (DFU)CHEMfootNCT07206862
CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds
A study testing DEBRICHEM® in people with Diabetic Foot Ulcer (DFU) and Diabetic Foot Ulcer Treatment, run by DEBx Medical B.V..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Diabetic Foot Ulcer Treatment, Diabetic Foot Wounds
- What is being tested?
- DEBRICHEM®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of the Addition of DEBRICHEM® to the Routine Management of Chronic Diabetic Foot Wounds: an Open-label Randomized Controlled Trial (CHEMfoot Study)
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.
Read the 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 often associated with biofilm formation, which sustains inflammation, delays healing, and reduces the efficacy of mechanical debridement and systemic treatments. New approaches targeting biofilm could improve wound outcomes.
DEBRICHEM® is a CE-marked (Class IIb) medical device developed by DEBx Medical B.V. It is a red, semi-fluid desiccant gel that rapidly binds water molecules in biological material, thereby disrupting biofilm and necrotic tissue. The gel is applied topically for 60 seconds and then rinsed with saline, replacing conventional mechanical debridement. Previous case series and observational data suggest DEBRICHEM® may accelerate granulation and wound closure. However, no randomized controlled trial has yet demonstrated its clinical benefit in diabetic foot ulcers.
The CHEMfoot study is a prospective, open-label, randomized controlled trial conducted at six centers in France. Adults with type 1 or type 2 diabetes and chronic foot ulcers (≥4 weeks, 0.5-10 cm², Texas grade 0-IIC) will be randomized 1:1 to:
Intervention arm: single topical application of DEBRICHEM® plus standard wound care.
Control arm: standard wound care alone, including mechanical debridement and appropriate dressings.
The primary endpoint is the proportion of patients with complete wound healing at 20 weeks, defined as 100% re-epithelialization, wound closure, and absence of exudate, confirmed by blinded investigators and an independent adjudication committee reviewing photographs.
Secondary outcomes include:
Complete healing at 8 and 12 weeks.
≥50% wound surface reduction at 4, 8, 12, and 20 weeks. Change in wound size over time. Local infection rates. Pain (Visual Analog Scale) before/after debridement and during dressing changes.
Quality of life (EQ-5D-5L, EQ-VAS) and sleep (Epworth Sleepiness Scale). Healthcare utilization (hospitalizations, antibiotic prescriptions). Usability of DEBRICHEM® by healthcare professionals (System Usability Scale). Safety outcomes include the incidence and type of adverse events (AE/SAE) related to DEBRICHEM®, as well as pain levels at predefined time points after application (immediately, 2 hours, 24 hours).
A total of 242 patients (121 per arm) will be enrolled to provide 80% power to detect a 20% absolute difference in healing rates (60% vs. 40%) at 20 weeks, assuming a 20% dropout rate. Randomization will be stratified by center and wound size (0.5-5 cm² vs. >5-10 cm²).
The study duration is 12 months (7 months recruitment, 5 months follow-up). Results will provide high-level evidence on whether DEBRICHEM® offers added value to the standard management of chronic diabetic foot ulcers.
- Being tested
- DEBRICHEM®
- Keywords
- chemical debridement, DEBRICHEM, topical desiccating agent, TDA, DFU, diabetic foot ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEBRICHEM®Device
Also called Topical Desiccating Agent, TDA, DEBRICHEM
Single topical application of DEBRICHEM® (desiccant gel for chemical debridement) at inclusion, then standard wound dressings and care.
| Study group | Role | What they receive |
|---|---|---|
| DEBRICHEM® + conventional wound care | Experimental | Single topical application of DEBRICHEM® (desiccant gel for chemical debridement) at inclusion, then standard wound dressings and care. Receives: Device: DEBRICHEM® |
| Conventional wound care only | No intervention | Mechanical debridement and wound dressing per standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 weeks
Secondary outcomes (11)
wound healing wk 8
Complete wound healing at 8
Measured: week 8
wound healing week 12
Complete wound healing at 12 weeks.
Measured: 12 weeks
Proportion of patients with ≥50% wound surface reduction
Proportion of patients with ≥50% wound surface reduction at weeks 4,8,12 and 20
Measured: 20 weeks
wound area change
Mean change in wound area (absolute cm² and relative %).
Measured: 20 weeks
Incidence of wound infection
Incidence of wound infection at week 4, 8, 12 and 20
Measured: 20 weeks
Quality of Iife
Health-related quality of life (EQ-5D-5L)
Measured: 20 weeks
Pain Score
Pain scores (Visual Analog Scale) before/after debridement, and during dressing changes.
Measured: 20 weeks
Sleep quality
Sleep quality (Epworth Sleepiness Scale).
Measured: 20 weeks
health resources
Health resource use: hospitalizations, antibiotic prescriptions.
Measured: 20 weeks
treatment usability
Usability of DEBRICHEM® (System Usability Scale questionnaire).
Measured: 20 weeks
Safety by adverse event monitoring
Safety: incidence and nature of adverse events and serious adverse events; pain assessment before, immediately after, 2h, 24h and 20 weeks after DEBRICHEM® application.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study startOct 2025 (estimated)
- Primary completion23 Dec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Interventional
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DEBx Medical B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ariane Sultan, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206862
- Sponsor's protocol ID
- CHEMfoot
- Acronym
- CHEMfoot
- Status last verified
- Oct 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Addition of DEBRICHEM® to the Routine Management of Chronic Diabetic Foot Wounds: an Open-label Randomized Controlled Trial (CHEMfoot Study)
- ClinicalTrials.gov ID
- NCT07206862
- Acronym / sponsor ID
- CHEMfoot / CHEMfoot
- Keywords
- chemical debridement, DEBRICHEM, topical desiccating agent, TDA, DFU, diabetic foot ulcer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- DEBx Medical B.V.Industry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 often associated with biofilm formation, which sustains inflammation, delays healing, and reduces the efficacy of mechanical debridement and systemic treatments. New approaches targeting biofilm could improve wound outcomes.
DEBRICHEM® is a CE-marked (Class IIb) medical device developed by DEBx Medical B.V. It is a red, semi-fluid desiccant gel that rapidly binds water molecules in biological material, thereby disrupting biofilm and necrotic tissue. The gel is applied topically for 60 seconds and then rinsed with saline, replacing conventional mechanical debridement. Previous case series and observational data suggest DEBRICHEM® may accelerate granulation and wound closure. However, no randomized controlled trial has yet demonstrated its clinical benefit in diabetic foot ulcers.
The CHEMfoot study is a prospective, open-label, randomized controlled trial conducted at six centers in France. Adults with type 1 or type 2 diabetes and chronic foot ulcers (≥4 weeks, 0.5-10 cm², Texas grade 0-IIC) will be randomized 1:1 to:
Intervention arm: single topical application of DEBRICHEM® plus standard wound care.
Control arm: standard wound care alone, including mechanical debridement and appropriate dressings.
The primary endpoint is the proportion of patients with complete wound healing at 20 weeks, defined as 100% re-epithelialization, wound closure, and absence of exudate, confirmed by blinded investigators and an independent adjudication committee reviewing photographs.
Secondary outcomes include:
Complete healing at 8 and 12 weeks.
≥50% wound surface reduction at 4, 8, 12, and 20 weeks. Change in wound size over time. Local infection rates. Pain (Visual Analog Scale) before/after debridement and during dressing changes.
Quality of life (EQ-5D-5L, EQ-VAS) and sleep (Epworth Sleepiness Scale). Healthcare utilization (hospitalizations, antibiotic prescriptions). Usability of DEBRICHEM® by healthcare professionals (System Usability Scale). Safety outcomes include the incidence and type of adverse events (AE/SAE) related to DEBRICHEM®, as well as pain levels at predefined time points after application (immediately, 2 hours, 24 hours).
A total of 242 patients (121 per arm) will be enrolled to provide 80% power to detect a 20% absolute difference in healing rates (60% vs. 40%) at 20 weeks, assuming a 20% dropout rate. Randomization will be stratified by center and wound size (0.5-5 cm² vs. >5-10 cm²).
The study duration is 12 months (7 months recruitment, 5 months follow-up). Results will provide high-level evidence on whether DEBRICHEM® offers added value to the standard management of chronic diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Interventional
| Arm | Type | Receives |
|---|---|---|
| DEBRICHEM® + conventional wound care | Experimental | Device: DEBRICHEM®Single topical application of DEBRICHEM® (desiccant gel for chemical debridement) at inclusion, then standard wound dressings and care. |
| Conventional wound care only | No intervention | –Mechanical debridement and wound dressing per standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (7 listed)
- Allergy to DEBRICHEM® components.
- Active malignancy, osteomyelitis, fasciitis, exposed cartilage.
- Revascularization <4 weeks prior.
- Systemic infection.
- Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEBRICHEM®Also: Topical Desiccating Agent, TDA, DEBRICHEMSingle topical application of DEBRICHEM® (desiccant gel for chemical debridement) at inclusion, then standard wound dressings and care. | Device | DEBRICHEM® + conventional wound care |
Primary outcome
Proportion of patients with complete wound healing at 20 weeks
Time frame: 20 weeks
100% wound surface closure, complete re-epithelialization, and absence of exudate, confirmed by blinded investigator and adjudication committee review of wound photographs.
11 secondary outcomes
wound healing wk 8
Time frame: week 8
wound healing week 12
Time frame: 12 weeks
Proportion of patients with ≥50% wound surface reduction
Time frame: 20 weeks
wound area change
Time frame: 20 weeks
Incidence of wound infection
Time frame: 20 weeks
Quality of Iife
Time frame: 20 weeks
Pain Score
Time frame: 20 weeks
Sleep quality
Time frame: 20 weeks
health resources
Time frame: 20 weeks
treatment usability
Time frame: 20 weeks
Safety by adverse event monitoring
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer (DFU)
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
Recruiting
Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
Diabetic Foot Ulcer, Foot Ulcer Chronic
Active, not recruiting
Remote Temperature and Visual Monitoring To Help Manage Diabetic Foot Ulcers
Diabetic Foot Ulcer (DFU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ariane Sultan, MD principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
A study testing DEBRICHEM® in people with Diabetic Foot Ulcer (DFU) and Diabetic Foot Ulcer Treatment, run by DEBx Medical B.V..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Snels, MSc (0031 85 0878096, info@debx-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with complete wound healing at 20 weeks (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.