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
Laboratoires URGO
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
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 a…
Interventions
- DeviceSaline solution
randomization to saline solution group for local management of venous or mixed leg ulcers
- DeviceVashe solution
randomisation to Vashe solution group for local management of venous or mixed leg ulcers
Location
- Comprehensive Wound Healing Center and Hyperbarics, Northwell HealthNew York, New York