Laboratoires URGO
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
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…
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
Arctuva estimate
Verify or correct the compensation shown for this listing.