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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Venous Leg Ulcer (VLU)
• Intervention / Treatment: Device: Vashe solution; Device: Saline solution

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

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clémence TUMBA, PharmD; Phone Number: 0033 + +33 3 80 44 74 09; Email: c.tumba@fr.urgo.com
• Study Contact Backup: Name: Olivier TACCA, PhD; Phone Number: 0033+ +33 3 80 44 74 22; Email: o.tacca@fr.urgo.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 11042
      • Comprehensive Wound Healing Center and Hyperbarics, Northwell Health
      • Contact: Alisha OROPALLO, Principal Investigator, MD; Email: Aoropallo@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vashe solution; Vashe solution is a wound irrigation solution that contain hypochlorous acid	Device: Vashe solution; randomisation to Vashe solution group for local management of venous or mixed leg ulcers
Active Comparator: Saline solution; Saline solution is an isotonic solution designed for irrigation purposes of wounds	Device: Saline solution; randomization to saline solution group for local management of venous or mixed leg ulcers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical success at week 4	Clinical success at Week 4, defined as a clinical score ≤ 1.	week 4

Collaborators and Investigators

• Sponsor: Laboratoires URGO

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: chronic wound; venous leg ulcer; inflammatory signs
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Skin and Connective Tissue Diseases; Varicose Ulcer; Surgical Procedures, Operative; Obstetric Surgical Procedures; Abortion, Induced
• Other Study ID Numbers: FI-25-09-AWC031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No