Evaluating Oxygen Therapy for Chronic Venous Leg Ulcers
A Multi-national, Prospective, Randomized, Double Blinded, Placebo-controlled Trial to Evaluate Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Venous Leg Ulcers
This study is testing if a new oxygen therapy can help heal chronic venous leg ulcers better than standard treatment in people who have these wounds.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AOTI Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06754735 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness, safety, and economic advantages of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in treating chronic venous leg ulcers (VLU). Participants will receive standard multilayer compression dressings and will be randomly assigned to either the TWO2 therapy or a sham control group after a two-week run-in period. The intervention lasts up to 16 weeks, followed by a long-term follow-up period of 52 weeks. The study seeks to understand the impact of oxygen on wound healing in patients suffering from VLUs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic venous leg ulcers below the knee that have persisted for at least 6 weeks.
Not a fit: Patients with ulcers not related to venous disease or those with contraindications to compression therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve healing rates and quality of life for patients with chronic venous leg ulcers.
How similar studies have performed: Other studies have shown promising results with oxygen therapy in wound healing, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Wound size reduction in a 2-week run-in period of ≤ 30% * Subject understands and is willing to participate in the clinical study and comply with weekly visits and follow up regime * Subject has read and signed IRB/EC approved ICF before screening procedures commence Exclusion Criteria: * • 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 * BMI \> 45 * Uncontrolled diabetes: HbA1c \> 12% within 60 days of screening * Renal dialysis or of screening EGFR less than 30 mg/dl * NYHA Class IV * Peripheral arterial reconstruction/revascularization on the affected limb within the last 30 days * Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids \> 10mg daily dose, immunosuppressive agents). * Active systemic treatment for malignancy * History of radiation at the ulcer site * Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayer cell therapy, dermal substitute, extracellular matrix) within 14 days before screening * Subject participated in another investigational device, drug or biological trial within four weeks prior to study entry * Subject may not be pregnant or breastfeeding at the time of treatment
Where this trial is running
New York, New York
- Vascular Institute of New York — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Anil Hingorani, MD
- Study coordinator: Despina Herodotou, MRCPod, DABPMi
- Email: despi.herodotou@aotinc.net
- Phone: 1-760-431-4700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.