EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMEN… (NCT07440797) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
United States102 participantsStarted 2026-03
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.