Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers

Eligibility 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
• * • 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