CClinicalTrials.gg
Not yet recruitingNCT07440797Updated Mar 4, 2026

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

An interventional study of Saline solution and Vashe solution in Venous Leg Ulcer (VLU), sponsored by Laboratoires URGO. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.

Sponsored by Laboratoires URGO · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Venous Leg Ulcer (VLU)

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Keywords

  • venous leg ulcer
  • inflammatory signs
  • chronic wound
03

In context

Varicose Ulcer

378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.

This study's planned enrollment of 102 is above the median of 64 across 325 interventional studies indexed under Varicose Ulcer.

Browse Varicose Ulcer studies →

Lead sponsor

Laboratoires URGO is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    Vashe solution

    Vashe solution is a wound irrigation solution that contain hypochlorous acid

    Device: Vashe solution

  • Active comparator
    Saline solution

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

    Device: Saline solution

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

06

What researchers measure

Primary outcomes

  1. clinical success at week 4

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

    Time frame: week 4

07

Study locations

1 site
  • Comprehensive Wound Healing Center and Hyperbarics, Northwell Health
    New York, New York 11042, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07440797
Lead sponsor
Laboratoires URGO
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Mar 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Mar 4, 2026

Study contacts

Clémence TUMBA, PharmD
Contact
c.tumba@fr.urgo.com
+33 3 80 44 74 09 ext. 0033 +
Olivier TACCA, PhD
Contact
o.tacca@fr.urgo.com
+33 3 80 44 74 22 ext. 0033+

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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