Back to search results

Trial to Evaluate Cyclical Topical Wound Oxygen Therapy for Venous Leg Ulcers

This study is looking at how well Cyclical Topical Wound Oxygen Therapy (TWO2) works to heal chronic venous leg ulcers (VLUs). VLUs are long-lasting sores on the leg caused by poor blood flow. Participants will receive either the TWO2 device, which delivers oxygen directly to the wound, or a sham device that delivers regular air. Everyone in the study will also receive standard care, which includes compression dressings. The main goal is to see how many wounds completely close within 16 weeks with the TWO2 therapy. You might be able to join if you are an adult aged 18 or older with a chronic VLU below the knee that is caused by venous disease.

Study design
This is an interventional study planning to enroll 212 participants. Participants will be randomly assigned to receive either the active oxygen therapy or a sham control therapy, in addition to standard care.
What's involved
After a 2-week period of standard care, you would participate in the intervention period for up to 16 weeks. This is followed by a long-term follow-up period of 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 52 weeks after they are randomly assigned to a treatment group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06754735

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
AOTI Ltd.
~212 participants
Updated 2025-11-19 on ClinicalTrials.gov
What's tested:Topical Wound Oxygen TherapySham Control Topical Wound Oxygen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of complete wound closure within 16 weeks with the use of Topical Wound Oxygen Therapy (TWO2)
Measured over From Baseline to16 weeks

Conditions

Venous Leg Ulcer (VLU)

Explore related trials

Stasis ulcer

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Mike Griffiths, DProf, DMS, CRT, FCMI · STUDY_CHAIR · AOTI Ltd.
  • Anil Hingorani, MD · PRINCIPAL_INVESTIGATOR
  • Wael Tawfick, MB.BCH, MRCSI. · PRINCIPAL_INVESTIGATOR · University of Galway

Who to contact

Despina Herodotou, MRCPod, DABPMi
[email protected]
1-760-431-4700
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

• 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

What this trial measures

  • Incidence of complete wound closure within 16 weeks with the use of Topical Wound Oxygen Therapy (TWO2)From Baseline to16 weeks

    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.