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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratoires URGO

About this trial

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

Eligibility criteria

Qualifiers

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...)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Saline solution
  • Vashe solution

Treatment groups

102 Participants
are divided into 2 treatment groups

Sponsors and collaborators