RECRUITING

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

Conditions

Venous Leg Ulcer (VLU)Ulcer, Wound, Randomized, Oxygen, Placebo, Sham, Venous, Compression Varicose Veins, Venous stasis ulcer Topical Oxygen

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06754735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* • 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

Inclusion Criteria

Exclusion 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

* • 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

Contacts and Locations

Study Contact

Despina Herodotou, MRCPod, DABPMi

CONTACT

1-760-431-4700

despi.herodotou@aotinc.net

Principal Investigator

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

Study Locations (Sites)

Vascular Institute of New York

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: AOTI Ltd.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-01

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Venous Leg Ulcer (VLU)