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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
randomization to saline solution group for local management of venous or mixed leg ulcers
randomisation to Vashe solution group for local management of venous or mixed leg ulcers
Comprehensive Wound Healing Center and Hyperbarics, Northwell Health
New York, New York, United States
clinical success at week 4
Clinical success at Week 4, defined as a clinical score ≤ 1.
Time frame: week 4
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