RecruitingPhase 4NCT06754735

Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of 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

Sponsor

AOTI Ltd.

Enrollment

212 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Venous Leg Ulcer (VLU)

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

Min Age: 18 Years

Inclusion Criteria11

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 Criteria19

• 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

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Interventions

DEVICETopical Wound Oxygen Therapy

The active intervention is the application of the Topical Wound Oxygen device that supplies cyclical oxygen pressure directly to the wound site within a sealed environment.

DEVICESham Control Topical Wound Oxygen

The sham control intervention is the application of Topical Wound Oxygen device that supplies topical room air to the wound site within a sealed environment.