Actively Recruiting
Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
Led by AOTI Ltd. · Updated on 2025-11-19
212
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older who can provide written informed consent
- Patients with a chronic venous leg ulcer below the knee at or above the malleolus caused by venous disease
- Venous reflux of 500 milliseconds or more in superficial veins or 1 second or more in deep veins, or venous mapping after vascular procedures
- Ulcer size between 1.5 cm² and 50 cm² after debridement at enrollment
- Cluster wounds with a total ulcer area of 50 cm² or less
- Ulcer present for at least 6 weeks and no more than 5 years before study entry
- Ulcer has been treated with conventional compression dressing of at least 30 mmHg for 6 weeks before screening
- Adequate blood flow measured by Ankle-Brachial Pressure Index between 0.75 and 1.24 or other specified vascular measurements
- Wound size reduction of 30% or less during a 2-week run-in period
- Willingness and ability to participate and comply with study visits and follow-up
- Signed informed consent before screening procedures
You will not qualify if you...
- Allergy to any study treatments or intolerance to multilayer compression therapy
- Acute thrombophlebitis or deep vein thrombosis within 3 months before study
- Scheduled for venous ablation or less than 30 days since venous ablation
- Surgery such as abdominal, gynecological, hip, or knee replacement within 3 months before study
- Wound of uncertain cause or history of certain inflammatory or autoimmune ulcerations
- Evidence of bone infection in the affected limb
- Ulcer exposing bone, muscle, or tendon
- Signs of unmanaged severe wound infection requiring hospitalization or surgery
- Body mass index over 45
- Uncontrolled diabetes with HbA1c over 12% within 60 days before screening
- Renal dialysis or estimated glomerular filtration rate less than 30 mg/dl
- New York Heart Association Class IV heart failure
- Peripheral arterial reconstruction or revascularization within 30 days before study
- Medications that may interfere with study treatment like high-dose steroids or immunosuppressants
- Active cancer treatment
- History of radiation at the ulcer site
- Use of growth factor therapies within 14 days before screening
- Participation in another investigational trial within 4 weeks before study
- Pregnancy or breastfeeding at time of treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vascular Institute of New York
New York, New York, United States, 10016
Actively Recruiting
Research Team
D
Despina Herodotou, MRCPod, DABPMi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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