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New dressing aims to heal infected leg ulcers faster

NCT ID NCT07211243

Disease control Sponsor: Lohmann & Rauscher Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two versions of a special wound dressing for infected leg ulcers. One has an extra protective film on top. About 150 adults with infected leg ulcers will be randomly assigned to one dressing or the other, along with compression therapy. The main goal is to see which dressing causes less skin damage (maceration) after three weeks.

What this could mean

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

Active substance
PHMB-impregnated biocellulose wound dressing with or without a polyethylene film top layer
What this could lead to
If it works, this could lead to a better dressing that reduces skin damage and speeds healing for infected leg ulcers.
What could go wrong
This is an early-stage study with only 150 people, so results may not apply to everyone. The dressing may not improve healing or could cause skin irritation.

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 150 people

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

Started

Sep 2025

Expected to finish

Jun 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: * Age ≥ 18 years * Infected\* venous\*\* leg ulcer * Slightly to moderately exuding wound\*\*\* * Patient has signed informed consent * as per CDC definition, also TILI score ≥ 5 \*\* ABPI \> 0.8 and \< 1.2 \*\*\* patients with highly exuding wounds may be screened for a 7 days run-in period to receive superabsorbent dressing and monitored compression therapy and re-con-sidered for enrolment in case the exudation level decreases Exclusion Criteria: * Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomisation and during the whole duration of this study * Wounds with exposed cartilage tissue (hyaline cartilage) * Contraindications to compression therapy (e.g.: advanced peripheral ar-terial occlusive diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin) * Known allergy and/or hypersensitivity to any components of the study product or concomitant products (e.g. compression bandage) * Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and / or interpreta-tion of the study results.

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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.

Venous leg ulcer

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 names and 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

  • Centrum Medyczne Ultramed

    WITHDRAWN

    Krakow, Poland

  • ClinicMed Daniluk, Nowak Spółka Komandytowa OŚRODEK LECZENIA RAN i Owrzodzeń

    RECRUITING

    Bialystok, 15-879, Poland

  • Lecran - Centrum Opieki Nad Ranami-Kunickiego

    RECRUITING

    Wroclaw, Poland

  • MelissaMed Poradnia Chirurgiczna

    WITHDRAWN

    Lodz, Poland

  • Mikomed Spółka Z Ograniczoną Odpowiedzialnością

    RECRUITING

    Lodz, Poland

  • Niepubliczny Zakład Opieki Zdrowotnej "Argo" Centrum Medyczne

    RECRUITING

    Lodz, Poland

  • PP CLINIC Pietrzyk spółka partnerska lekarzy

    RECRUITING

    Lublin, Poland

  • SPECJALISTYCZNY OSRODEK LECZNICZO BADAWCZY, Zbigniew Żęgota

    RECRUITING

    Ostróda, Poland

  • Specjalistyczna Pomoc Medyczna "Medservice"

    RECRUITING

    Zabrze, Poland

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