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Single gel application may speed healing of diabetic foot wounds

NCT ID NCT07206862

Disease control Sponsor: DEBx Medical B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a gel called DEBRICHEM® that is applied once to chronic diabetic foot ulcers to remove biofilm and help the wound heal. About 242 adults with foot ulcers that have not improved for at least 4 weeks will be randomly assigned to receive standard wound care plus the gel or standard care alone. The main goal is to see if more people achieve complete wound healing by 20 weeks with the gel.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DEBRICHEM® (a desiccant gel applied once to chemically debride the wound)
What this could lead to
If it works, this gel could help diabetic foot ulcers heal faster and reduce the risk of infection, hospitalization, or amputation.
What could go wrong
This is an early-stage trial with no phase designation, so results are uncertain. The gel is applied only once, and its benefit over standard care alone is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 242 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot ulcer (DFU) Diabetic foot ulcer treatment Diabetic foot wounds

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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More trials for these conditions

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