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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07440797

Enrollment

102

Registered

2026-02-27

Start date

2026-03-01

Completion date

2027-03-01

Last updated

2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Leg Ulcer (VLU)

Keywords

venous leg ulcer, inflammatory signs, chronic wound

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

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

DEVICESaline solution

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

DEVICEVashe solution

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open label trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTClémence TUMBA, PharmD

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

CONTACTOlivier TACCA, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026