Venous Leg Ulcer (VLU)NCT07440797
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
A study testing Saline solution and Vashe solution in people with Venous Leg Ulcer (VLU), run by Laboratoires URGO at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer (VLU)
- What is being tested?
- Saline solution and Vashe solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Comprehensive Wound Healing Center and Hyperbarics, Northwell Health
New York, New York, 11042
Alisha OROPALLO, Principal Investigator, MD, Aoropallo@northwell.edu
About this study
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
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
- Conditions
- Venous Leg Ulcer (VLU)
- Being tested
- Saline solution, Vashe solution
- Keywords
- venous leg ulcer, inflammatory signs, chronic wound
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline solutionDevice
randomization to saline solution group for local management of venous or mixed leg ulcers
Vashe solutionDevice
randomisation to Vashe solution group for local management of venous or mixed leg ulcers
| Study group | Role | What they receive |
|---|---|---|
| Vashe solution | Experimental | Vashe solution is a wound irrigation solution that contain hypochlorous acid Receives: Device: Vashe solution |
| Saline solution | Active comparator | Saline solution is an isotonic solution designed for irrigation purposes of wounds Receives: Device: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success at week 4
Clinical success at Week 4, defined as a clinical score ≤ 1.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg Ulcer (VLU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label trial
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires URGO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440797
- Sponsor's protocol ID
- FI-25-09-AWC031
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07440797
- Acronym / sponsor ID
- FI-25-09-AWC031
- Conditions
- Venous Leg Ulcer (VLU)
- Keywords
- venous leg ulcer, inflammatory signs, chronic wound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Laboratoires URGOIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label trial
| Arm | Type | Receives |
|---|---|---|
| Vashe solution | Experimental | Device: Vashe solutionVashe solution is a wound irrigation solution that contain hypochlorous acid |
| Saline solution | Active comparator | Device: Saline solutionSaline solution is an isotonic solution designed for irrigation purposes of wounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline solutionrandomization to saline solution group for local management of venous or mixed leg ulcers | Device | Saline solution |
| Vashe solutionrandomisation to Vashe solution group for local management of venous or mixed leg ulcers | Device | Vashe solution |
Primary outcome
clinical success at week 4
Time frame: week 4
Clinical success at Week 4, defined as a clinical score ≤ 1.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline solution and Vashe solution in people with Venous Leg Ulcer (VLU), run by Laboratoires URGO at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clémence TUMBA, PharmD (+33 3 80 44 74 09 ext. 0033 +, c.tumba@fr.urgo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical success at week 4 (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.