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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Saline solution, Vashe solution.
- Who it may be relevant to
- Registry conditions: Venous Leg Ulcer (VLU). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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
Interventions
- Device Saline solution
randomization to saline solution group for local management of venous or mixed leg ulcers - Device Vashe solution
randomisation to Vashe solution group for local management of venous or mixed leg ulcers
Primary outcome measures
- clinical success at week 4 [Time frame: week 4]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Comprehensive Wound Healing Center and Hyperbarics, Northwell Health — New York
Identifiers
NCT: NCT07440797 · FI-25-09-AWC031