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Can a simple solution beat saline for infected leg ulcers?

NCT ID NCT07440797

Symptom relief Sponsor: Laboratoires URGO 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compares Vashe solution, a wound cleanser, to standard saline for treating leg ulcers that show signs of heavy bacterial infection. About 102 adults with venous or mixed leg ulcers will be randomly assigned to one of the two solutions. The goal is to see if Vashe reduces inflammation and is safe to use.

What this could mean

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

Active substance
Vashe solution (a wound cleansing solution)
What this could lead to
If it works, Vashe could become a standard option for reducing infection signs in leg ulcers, speeding up healing.
What could go wrong
This is a small early trial (102 people) comparing to saline, not a proven treatment. Results may not show clear benefit or could be limited to specific ulcer types.

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 102 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 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: * Adult patient, at least 18 years of age or older who has provided free, written, and informed consent, * Patient who has already worn compression therapy in the past and agrees to wear the two-layer compression system during the whole treatment period, * Patient presenting a venous or mixed leg ulcer predominantly of venous origin (ABPI between ≥0.8≤1.3, * Leg ulcer presenting at least 3 inflammatory signs (e.g pain, erythema...) * Target leg ulcer located at least 3 cm from the edge of another wound. Exclusion Criteria: * Pregnant or breastfeeding patient, * Patient already participating in another clinical trial, except observational trial * Patient with epifascial arterial bypass (superficial arterial bypass) * Patient suffering from phlegmatia coerulea dolens, septic phlebitis, acute deep vein thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated. * Patient receiving or having received systemic antibiotics within the ten days prior to inclusion in the investigation, regardless of therapeutic class or indication, * Cancerous wound.

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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 (VLU)

How to take part

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

  1. The places running it

    1 site. 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

  • Comprehensive Wound Healing Center and Hyperbarics, Northwell Health

    New York, New York, 11042, United States

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