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

NCT07440797 | Not Yet Recruiting FDA Device

• 1 other identifier: FI-25-09-AWC031
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Leg Ulcer (VLU)

Keywords

venous leg ulcer; inflammatory signs; chronic wound

Outcome Measures

Primary Outcomes (1)

• clinical success at week 4

  Clinical success at Week 4, defined as a clinical score ≤ 1.

  week 4

Study Arms (2)

Vashe solution

EXPERIMENTAL

Vashe solution is a wound irrigation solution that contain hypochlorous acid

Device: Vashe solution

Saline solution

ACTIVE COMPARATOR

Saline solution is an isotonic solution designed for irrigation purposes of wounds

Device: Saline solution

Interventions

Saline solution DEVICE

randomization to saline solution group for local management of venous or mixed leg ulcers

Saline solution

Vashe solution DEVICE

randomisation to Vashe solution group for local management of venous or mixed leg ulcers

Vashe solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Cancerous wound.

Sponsors & Collaborators

• Laboratoires URGO: lead

Study Sites (1)

Comprehensive Wound Healing Center and Hyperbarics, Northwell Health

New York, New York, 11042, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Abortion, Induced

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Clémence TUMBA, PharmD

CONTACT

+33 3 80 44 74 09; c.tumba@fr.urgo.com

Olivier TACCA, PhD

CONTACT

+33 3 80 44 74 22; o.tacca@fr.urgo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label trial

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)