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

URGO Group

Status: Not yet enrolling

Conditions: Venous Leg Ulcer (VLU)

Treatments: Device: Saline solution; Device: Vashe solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT07440797

FI-25-09-AWC031

Details and patient eligibility

About

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

Full description

This study is carried out in United States of America in around 10 investigator sites. A total of 102 patients meeting the eligibility criteria will be included

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Vashe solution

Experimental group

Description:

Vashe solution is a wound irrigation solution that contain hypochlorous acid

Treatment:

Device: Vashe solution

Saline solution

Active Comparator group

Description:

Saline solution is an isotonic solution designed for irrigation purposes of wounds

Treatment:

Device: Saline solution