Can a special gel heal diabetic foot ulcers faster?

NCT ID NCT07783087

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This trial is testing whether an investigational wound gel called VES-0-D can help heal mild-to-moderate diabetic foot ulcers better than standard wound care. Adults with type 1 or type 2 diabetes and a foot ulcer will receive either the gel or a standard dressing, applied every 3-4 days for 8 weeks. The main goal is to see how much the wound shrinks in size, and the trial will also track wound healing scores and any side effects at the application site.

What this could mean

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

Active substance
VES-0-D wound gel, a topical medical device that manages moisture on open wounds
What this could lead to
If it works, this gel could offer a simple, non-invasive way to speed healing of diabetic foot ulcers, potentially reducing the risk of complications like infections or amputations.
What could go wrong
This is a small, early-stage trial with only 64 participants, so results may not apply to everyone. The gel may not heal ulcers faster than standard care, and there is a risk of skin irritation or infection at the application site.

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 64 people

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

Started

Aug 2026

Expected to finish

Oct 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: 1. The subject has signed an IEC-approved study informed consent form 2. The subject is male or female, at least 18 years of age at the date of screening 3. The subject has a confirmed diagnosis of Type 1 or Type 2 diabetes mellitus 4. The subject has a body mass index (BMI) of less than 40 kg/m2 5. The subject has an index ulcer with visible margins, having an area of ≥ 0.5 and ≤ 10.0 cm2 when measured by the electronic measuring device at screening 6. The index ulcer has been present for less than 12 months 7. The index ulcer is located on the plantar surface, toe or interdigital, heel, lateral or medial surface of the foot 8. The index ulcer does not extend beyond the subcutaneous tissue 9. The subject has an ABI \> 0.6 to \< 1.3 or TcPO2 ≥ 40 mmHg on the dorsum of the affected foot, or a great toe pressure ≥ 50 mmHg on the affected foot. Duplex ultrasound of the lower limb arteries is an acceptable alternative test but must show a peak systolic velocity ratio of \<2 for at least one of the posterior tibial, dorsalis pedis, and peroneal arteries. 10. The subject has peripheral neuropathy evidenced by a Semmes Weinstein monofilament test. 11. The subject is willing and able to return for all mandatory visits as defined in the protocol 12. The subject is willing and able to follow the instructions of the Investigator Exclusion Criteria: 1. The subject's index ulcer is primarily located on the dorsal surface of the foot 2. The target ulcer probes to bone or is complicated by osteomyelitis or abscess formation 3. The subject has a contralateral major amputation of the lower extremity 4. The subject has more than 2 ulcers on the index foot (if there are two ulcers, the larger will be chosen as the index ulcer for treatment) 5. The index ulcer is exudating heavily (subjects may be re-screened after heavy exudation is resolved) 6. The subject has a glycated hemoglobin (HbA1c) level of \> 8.0% (historical data may be used from within 6 months prior to screening) 7. The subject has been on oral steroid \> 7.5 mg daily for greater than seven (7) consecutive days in the 30 days before Screening 8. The subject has been on parenteral corticosteroids, or any cytotoxic agents for seven consecutive days in the period of 30 days before Screening 9. The subject is unable to sustain off-loading as defined by the protocol 10. The subject has an allergy to any component of the test article 11. The index ulcer is over an acute Charcot deformity 12. The subject is a member of a vulnerable population (e.g., prisoner, employee or family member of Sponsor or site staff, minor child, significant intellectual deficit) 13. Per Investigator's discretion the subject is not appropriate for inclusion in the investigation 14. Female patients who are pregnant or lactating

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Sint-Lucas

    NOT_YET_RECRUITING

    Bruges, West-Vlaanderen, 8310, Belgium

  • AZ Sint-Maarten

    ACTIVE_NOT_RECRUITING

    Mechelen, Antwerp, 2800, Belgium

  • CHU de Liège - Sart Tilman

    NOT_YET_RECRUITING

    Liège, Liège, 4000, Belgium

  • Grand Hôpital de Charleroi - Les Viviers

    NOT_YET_RECRUITING

    Charleroi, Henegouwen, 6060, Belgium

  • Hôpital d'Arlon - Vivalia

    NOT_YET_RECRUITING

    Arlon, Luxemburg, 6700, Belgium

  • Imeldaziekenhuis

    RECRUITING

    Bonheiden, Antwerp, 2820, Belgium

  • UZ Gent

    NOT_YET_RECRUITING

    Ghent, East-Flanders, 9000, Belgium

  • UZ Leuven

    NOT_YET_RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

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