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

Launched by AOTI LTD. · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Cyclical Topical Wound Oxygen Therapy (TWO2) for people with chronic venous leg ulcers (VLUs). These are wounds on the leg that can be difficult to heal and are often caused by poor blood flow in the veins. The trial will compare the effectiveness of TWO2 therapy combined with standard wound care to a placebo treatment that does not include the active therapy. Participants will first use standard care for two weeks, and then they will be randomly assigned to either the TWO2 therapy group or the control group for up to 16 weeks. After the treatment period, there will be follow-up evaluations for a year.

To be eligible for this trial, participants must be at least 18 years old, have a chronic VLU below the knee that has been present for at least six weeks, and have a certain level of blood flow in their legs. They should also be able to attend weekly visits for monitoring. Those with certain health conditions, allergies to treatments, or recent surgeries may not qualify. If you or a loved one are dealing with a chronic leg ulcer and are interested in learning more about this study, it could be a good opportunity to explore a potential new treatment option.

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ALL

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