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
Starting soon · Not applicable
Conditions studied: Venous Leg Ulcer (VLU)
In brief
Evaluation of the efficacy (reduction of inflammatory signs suggesting a local infection) and tolerance (emergence and nature of adverse event) of Vashe solution vs Saline solution in the treatment of venous or mixed leg ulcers presenting inflammatory signs suggesting heavy bacterial load
Key facts
- Study ID
- NCT07440797
- Run by
- Laboratoires URGO
- People needed
- 102
- Starts
- 2026-03-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Comprehensive Wound Healing Center and Hyperbarics, Northwell Health — New York, New York, United States
Full record on ClinicalTrials.gov
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