Topical Wound Oxygen Therapy for Leg Ulcers
(VaLUe I Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy, safety and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of venous leg ulcers. Participants will utilize standard of care (SOC) multilayer compression dressings with an inactive wound contact layer. Following a 2-week run-in period with SOC and after meeting all eligibility criteria, subjects will be randomized in a 1:1 ratio with TWO2 therapy or sham control therapy plus SOC. Participants will enter the intervention period of up to 16-weeks, followed by a long-term follow-up period of 52 weeks post randomization.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on medications like systemic steroids over 10mg daily or immunosuppressive agents, these might interfere with the study treatment, so it's best to discuss with the study team.
Is topical wound oxygen therapy safe for humans?
How does Topical Wound Oxygen Therapy differ from other treatments for leg ulcers?
Topical Wound Oxygen Therapy is unique because it delivers oxygen directly to the wound site, which can help promote healing by improving oxygen availability in the tissue. Unlike systemic oxygen therapies, it is non-invasive, can be administered at home, and does not carry the risk of oxygen toxicity.12367
What data supports the effectiveness of the treatment Topical Wound Oxygen Therapy for Leg Ulcers?
Research suggests that topical oxygen therapy can help heal difficult wounds, like diabetic foot ulcers and pressure ulcers, by reducing wound size and improving healing. Although more high-quality studies are needed, some evidence shows it may be a useful second option when other treatments don't work.26789
Who Is on the Research Team?
Mike Griffiths, DProf, DMS, CRT, FCMI
Principal Investigator
AOTI Ltd.
Anil Hingorani, MD
Principal Investigator
Wael Tawfick, MB.BCH, MRCSI.
Principal Investigator
University of Galway
Are You a Good Fit for This Trial?
This trial is for individuals with chronic venous leg ulcers who have been using standard multilayer compression dressings. Participants must complete a 2-week period with these dressings before starting the trial and meet all other requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants undergo a run-in period with standard of care (SOC) multilayer compression dressings
Treatment
Participants receive either TWO2 therapy or sham control therapy plus SOC for up to 16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sham Control Topical Wound Oxygen
- Topical Wound Oxygen Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
AOTI Ltd.
Lead Sponsor