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New bandage tested for leg ulcer healing

NCT ID NCT07600489

Disease control Sponsor: Molnlycke Health Care AB 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two types of compression bandages for treating venous leg ulcers, which are slow-healing wounds on the lower leg. About 386 adults will receive either the new Mepi Press 2 or the standard UrgoK2 bandage for up to 12 weeks. The goal is to see if the new bandage works as well at healing the ulcers completely.

What this could mean

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

Active substance
Compression bandage system (Mepi Press 2)
What this could lead to
If successful, this could offer a new, equally effective option for treating venous leg ulcers with compression therapy.
What could go wrong
This is a non-inferiority trial comparing two existing devices, so no major breakthrough is expected. Results may show similar effectiveness, not superiority.

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 386 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2028

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: * Patients ≥ 18 years. * Stage C6 venous leg ulcer diagnosed less than 24 months ago. * 2cm² ≤ VLU surface area ≤ 40cm². * ABPI equal or higher than 0.8 and equal or lower than 1.3. * Able to read, understand and speak French for their medical care. * Agreeing to follow the procedures described in the CIP. * Benefiting from a social insurance coverage. Exclusion Criteria: * Any contraindication to investigational or comparator medical devices mentioned in their respective IFUs. * Planned endovenous treatment or surgical venous stripping / exeresis within 8 weeks before planned inclusion date, or before end of participation to the study. * Treatment with chemotherapy or antineoplastic agent within the last 6 months. * Active wound infection or wound infection treatment within the past 4 weeks before inclusion or current use of silver dressings. * Pregnant or breastfeeding women. * Persons deprived from their liberty. * Persons protected under guardianship or curatorship. * Any person who, as per investigator's decision, is not suitable to participate in the investigation for any other reason.-

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Conditions

The condition(s) this trial relates to.

ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

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

Compression bandages Venous leg ulcer (VLU)

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 places running it

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

  3. 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 ↗

  4. 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

  • CHU Michallon Grenoble

    Grenoble, France

  • CHU Nantes

    Nantes, France

  • CHU Toulouse/Hopital Rangueil

    Toulouse, France

  • Clinique Pasteur-Toulouse

    Toulouse, France

  • Clinique du Parc Lyon

    Lyon, France

    Contact Email: •••••@•••••

  • Clinique du Parc-Montpellier

    Castelnau-le-Lez, France

  • Hopital Edouard Herriot_HCL

    Lyon, France

  • Poitiers Polyclinique

    Poitiers, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.