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

Part of paid clinical trials in New York, New York.

Sponsor
Laboratoires URGO
Study ID
NCT07440797
Status
Not Yet Recruiting

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Conditions

  • Venous Leg Ulcer (VLU)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Saline solution — DEVICE
    randomization to saline solution group for local management of venous or mixed leg ulcers
  • Vashe solution — DEVICE
    randomisation to Vashe solution group for local management of venous or mixed leg ulcers

Study Details

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

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vashe solution
    Vashe solution is a wound irrigation solution that contain hypochlorous acid
  • Active Comparator: Saline solution
    Saline solution is an isotonic solution designed for irrigation purposes of wounds

Primary Outcome Measure

clinical success at week 4 [ Time Frame: week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Comprehensive Wound Healing Center and Hyperbarics, Northwell HealthNew YorkNew York11042
Alisha OROPALLO, Principal Investigator, MD
[email protected]

Find similar trials in New York, NY

By research site
Comprehensive Wound Healing Center and Hyperbarics, Northwell Health· New York, NY

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