Recruiting

Cyclical Topical Oxygen Therapy

Sponsor:

AOTI Ltd.

Code:

NCT06754735

Conditions

Venous Leg Ulcer (VLU)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Topical Wound Oxygen Therapy

Sham Control Topical Wound Oxygen

Study Details

Brief 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.

Conditions

Venous Leg Ulcer (VLU)

Study ID

NCT06754735

Start date

Jan 15, 2025

Status verified date

Nov, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

212 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Topical Wound Oxygen Therapy Device

Topical Wound Oxygen (TWO2) device in combination with the extremity chamber delivers oxygen and cyclical compression to the wound site. The sealed environment created by the extremity chamber is filled with oxygen for a minimum of 120 minutes, 5 times a week over multilayered compression dressings and a wound contact layer.

sham comparator: Sham Control Topical Wound Oxygen (TWO2) device

A Sham Control Topical Wound Oxygen (TWO2) device in combination with the extremity chamber that does not deliver oxygen and cyclical compression to the wound site. The sealed environment created by the extremity chamber is filled with room air for a minimum of 120 minutes, 5 times a week over multilayered compression dressings and a wound contact layer.

Interventions

Topical 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.

Sham 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Despina Herodotou, MRCPod, DABPMi

1-760-431-4700despi.herodotou@aotinc.net

Locations

Vascular Institute of New York

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

AOTI Ltd.

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

  • Ulcer, Wound, Randomized, Oxygen, Placebo, Sham, Venous, Compression
  • Varicose Veins, Venous stasis ulcer
  • Topical Oxygen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AOTI Ltd. on 2025-11-19.