Vashe Solution for Venous Ulcers

CT
OT
Overseen ByOlivier TACCA, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Laboratoires URGO
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of Vashe solution compared to saline solution for treating leg ulcers with signs of infection. Vashe solution contains hypochlorous acid to help clean wounds, while saline solution is a saltwater mix often used for the same purpose. Individuals with a leg ulcer due to vein issues and at least three signs of inflammation, such as pain or redness, may qualify for this trial. Participants should have previously used compression therapy and agree to continue it during the trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding new treatment options for leg ulcers.

Will I have to stop taking my current medications?

The trial requires that you have not taken systemic antibiotics (medications that fight infections throughout the body) in the ten days before joining. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Vashe solution, containing hypochlorous acid, is generally safe for treating wounds. Studies and safety information indicate it is non-toxic and does not cause stinging. It effectively cleans and rinses wounds, such as ulcers and burns, without known harmful effects when used correctly. No long-term symptoms have been linked to its use, and it is not expected to be harmful if accidentally swallowed. However, individuals sensitive to hypochlorous acid should avoid it. Overall, research considers Vashe solution a safe choice for wound care.12345

Why are researchers excited about this trial's treatments?

Vashe solution is unique because it contains hypochlorous acid, which is known for its antimicrobial properties. Unlike traditional saline solutions that primarily serve to rinse and clean wounds, Vashe solution actively targets bacteria, potentially reducing infection risk in venous ulcers. Researchers are excited about this treatment because it offers a dual action by both cleansing the wound and providing an antibacterial effect, which could lead to faster healing and better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for venous ulcers?

This trial will compare the effectiveness of Vashe solution and saline solution in treating venous ulcers. Studies have shown that Vashe solution, which contains hypochlorous acid, effectively heals wounds. Specifically, research indicates that 86% of wounds treated with Vashe solution healed, with reduced pain and odor. Another study found that wounds treated with hypochlorous acid solutions healed completely. The solution cleans the wound and reduces bacteria, aiding healing. It is considered more effective than saline for complex wounds, such as venous ulcers.26789

Are You a Good Fit for This Trial?

This trial is for adults with a venous or mostly venous leg ulcer showing at least three signs of inflammation (like pain or redness). Participants must have used compression therapy before, agree to wear special bandages during treatment, and have only one target ulcer that's not too close to another wound.

Inclusion Criteria

My leg ulcer shows at least three signs of inflammation.
I have used compression therapy before and agree to use a two-layer system during treatment.
I have a leg ulcer mainly caused by vein problems.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Vashe solution or Saline solution for wound irrigation

4 weeks
Weekly visits for treatment assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Saline solution
  • Vashe solution

Trial Overview

The study compares two cleaning solutions—Vashe solution and regular saline—to see which works better and is safer for treating inflamed leg ulcers that may be infected. Patients are randomly assigned to receive either Vashe or saline along with standard care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Vashe solutionExperimental Treatment1 Intervention
Group II: Saline solutionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Laboratoires URGO

Lead Sponsor

Trials
16
Recruited
3,000+

Citations

(PDF) Evaluation of Vashe Wound Therapy in the Clinical ...

Vashe Wound Therapy (hypochlorous acid, produced on site and on demand) was used as an adjunct to a standard wound care protocol. Wound healing, reduction of ...

Effects of Hypochlorous Acid Solutions on Venous Leg Ulcers ...

All 1249 venous leg ulcers reported in this data set were healed completely. ... From this experience we conclude that aggressive management of VLUs results in ...

Cost-Effectiveness of Hypochlorous Acid Preserved Wound ...

A recent prospective clinical study found low-frequency ultrasound debridement with HAPWOC to be more effective than saline for complex wounds.7 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/20664326/

Evaluation of Vashe Wound Therapy in the clinical ...

Main outcome measures: Wound healing, reduction of pain, and odor. Main results: At the end of the study, 86% of all lesions healed, and the average size of ...

Vashe Wound Solution – A Pure Hypochlorous Acid Solution

Vashe® Wound Solution is a sting-free, no-contraindication skin cleanser for debriding and irrigating wounds, ulcers, burns, grafts, and non-intact skin.

Vashe® Wound Solution SAFETY DATA SHEET

Symptoms/Injuries After Ingestion: Ingestion is not expected to be harmful. Chronic Symptoms: None known. 4.3. Indication of Any Immediate ...

Cost-Effectiveness of Hypochlorous Acid Preserved Wound ...

A recent clinical study compared hypochlorous acid preserved wound cleanser (HAPWOC) to saline and found HAPWOC to be a more effective adjunct ...

FEB 14i2013 - accessdata.fda.gov

Vashe* Wound Therapy Solution is intended for cleansing, irrigating, moistening, and dlebriding acute and chronic dermal lesions, such as Stage ...

Vashe Wound Solution

Contraindications • Do not use for clients with known sensitivity to Hypochlorous Acid. • Do not use with Biodebridement (maggot) dressings. • Do not use in the ...