NCT06754735 Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
| NCT ID | NCT06754735 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | AOTI Ltd. |
| Condition | Venous Leg Ulcer (VLU) |
| Study Type | INTERVENTIONAL |
| Enrollment | 212 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 212 participants in total. It began in 2025-01-15 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Mike Griffiths, DProf, DMS, CRT, FCMI
STUDY CHAIR
AOTI Ltd.
Frequently Asked Questions
Who can join the NCT06754735 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Venous Leg Ulcer (VLU). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06754735 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06754735 currently recruiting?
Yes, NCT06754735 is actively recruiting participants. Contact the research team at despi.herodotou@aotinc.net for enrollment information.
Where is the NCT06754735 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06754735 clinical trial?
NCT06754735 is sponsored by AOTI Ltd.. The principal investigator is Mike Griffiths, DProf, DMS, CRT, FCMI at AOTI Ltd.. The trial plans to enroll 212 participants.