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: MULTICENTER, PROSPECTIVE, OPEN-LABEL, RANDOMIZED CONTROLLED TRIAL
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Laboratoires URGO
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- clinical success at week 4
Overview
Brief 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
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Vashe solution
Vashe solution is a wound irrigation solution that contain hypochlorous acid
Intervention: Vashe solution (Device)
Saline solution
Saline solution is an isotonic solution designed for irrigation purposes of wounds
Intervention: Saline solution (Device)
Outcomes
Primary Outcomes
clinical success at week 4
Time Frame: week 4
Clinical success at Week 4, defined as a clinical score ≤ 1.
Secondary Outcomes
No secondary outcomes reported