Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: AOTI Ltd.
You may qualify if…
- ✓ Adults ≥ 18 years and able to provide written informed consent
- ✓ Patients who have a chronic venous leg ulcer (VLU) below the knee at or above the malleolus determined to be due to underlying venous disease
- ✓ Venous reflux ≥ 500 mil sec/superficial or 1 sec/deep or venous mapping after interventions following a vascular procedure
- ✓ VLU of ≥ 1.5cm2 and ≤ 50cm2 after debridement at study enrolment i.e. Screening visit
- ✓ \*Cluster wounds where the sum of the full thickness ulcer area must be ≤ 50cm2
- ✓ Study ulcer (current episode of ulceration in case of ulcer recurrence) has been present for at least 6 weeks but no more than 5 years prior to study entry
- ✓ The index ulcer has been treated with CCD of at least 30mmHg for ≥ 6 weeks prior to screening.
- ✓ Adequate perfusion with Ankle-Brachial Pressure Index (ABPI) of 0.75-1.24 inclusive measured at study entry or within 8 weeks prior to study entry AND TcpO2 \> 30mmHg OR Biphasic arterial duplex below the knee OR Toe pressure \> 30mmHg OR TBI .6
You may not qualify if…
- ✕ • Known allergy to any of the protocol-stipulated treatments, or non-tolerance of multilayer, multicomponent compression therapy
- ✕ Acute thrombophlebitis or Deep Vein Thrombosis (DVT) and within three months preceding study entry
- ✕ Subject awaiting venous ablation or is less than 30 days post ablation
- ✕ Surgery during three months prior to study entry (such as abdominal, gynecological, hip or knee replacement)
- ✕ Wound etiology of uncertain origin or history or prior diagnosis of Systemic Lupus Erythematosus, Burger's Disease, Pyoderma Gangrenosum or other inflammatory ulceration, vasculitis
- ✕ Documented evidence of osteomyelitis on any part of affected limb
- ✕ Index ulcer has exposed bone, muscle and tendon
- ✕ Index ulcer exhibits signs of unmanaged wound infection or severe clinical infection that requires hospitalization or immediate surgical intervention
Where it's recruiting
New York
Source: ClinicalTrials.gov · NCT06754735 · last updated 2025-11-19