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NOT YET RECRUITING
NCT07440797
NA

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

Sponsor: Laboratoires URGO

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2026-03

Completion Date

2027-03

Last Updated

2026-03-04

Healthy Volunteers

No

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

Locations (1)

Comprehensive Wound Healing Center and Hyperbarics, Northwell Health

New York, New York, United States