Trial to Evaluate Cyclical Topical Wound Oxygen Therapy in the Treatment of Chronic Venous Leg Ulcers
ConditionVenous Leg Ulcer (VLU)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAOTI Ltd.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
• 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)
Trial design
Design model
Parallel
Treatments tested in this trial
Topical Wound Oxygen Therapy
DeviceThe 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.
Sham Control Topical Wound Oxygen
DeviceThe sham control intervention is the application of Topical Wound Oxygen device that supplies topical room air to the wound site within a sealed environment.
Treatment groups
212 Participants
are divided into 2 treatment groupsGroup A: Topical Wound Oxygen Therapy DeviceActive comparator 1 intervention
Group B: Sham Control Topical Wound Oxygen (TWO2) deviceSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of complete wound closure within 16 weeks with the use of Topical Wound Oxygen Therapy (TWO2)
Percentage incidence of complete wound closure defined as 100% skin re-epithelialization without the need for wound dressing that is confirmed by 2 consecutive study visits 2 weeks apart.
Time frame
From Baseline to16 weeksSecondary outcomes
1
Percentage Area Reduction (PAR)
Change in wound area will be documented bi-weekly by the use of digital photography and wound mapping
Time frame
Baseline, Week 2, 4, 6, 8, 10, 12, 14 up to 16 weeks (± 2 days)2
Incidence of complete wound closure at 12 weeks
Incidence of complete wound closure defined as 100% skin re-epithelialization without the need for wound dressing that is confirmed by 2 consecutive study visits 2 weeks apart.
Time frame
From Baseline to12 weeks3
Incidence of complete wound closure at 52 weeks
Incidence of complete wound closure defined as 100% skin re-epithelialization without the need for wound dressing that is confirmed by 2 consecutive study visits 2 weeks apart.
Time frame
From week 16 to 52 weeks4
Time to complete wound closure
Healing difference over Time will be assessed over a 16-week period
Time frame
Baseline, Week 2, 4, 6, 8, 10, 12, 14 up to 16 weeks (± 2 days), 20, 26, 52 weeks (± 2 weeks) Source ClinicalTrials.gov