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Vashe Solution vs. Saline for Venous Leg Ulcers

This study is looking at how well Vashe solution works compared to saline solution in treating venous or mixed leg ulcers that show signs of inflammation, which might mean there are a lot of bacteria. Researchers want to see if Vashe solution can reduce these inflammatory signs and if it's well-tolerated (meaning it doesn't cause too many side effects). You might be able to join if you are an adult, at least 18 years old, have a venous or mixed leg ulcer, and have used compression therapy before. The study will measure how successful the treatment is after 4 weeks. This study plans to include 102 patients and is currently recruiting.

Study design
This interventional study will include about 102 participants. Participants will be randomly assigned to either the Vashe solution group or the saline solution group.
What's involved
You would need to wear a two-layer compression system throughout the treatment period. The study will assess your clinical success at week 4.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for this study is measured at week 4, which suggests follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07440797

EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Laboratoires URGO
~102 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Saline solutionVashe solution

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
clinical success at week 4
Measured over week 4

Conditions

Venous Leg Ulcer (VLU)

Explore related trials

Mixed Leg UlcerStasis ulcer

Where it's being run

1 sites across 1 states
New York1

Who to contact

Clémence TUMBA, PharmD
[email protected]
+33 3 80 44 74 09 · ext. 0033 +
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • clinical success at week 4week 4

    Clinical success at Week 4, defined as a clinical score ≤ 1.