Evaluating Oxygen Therapy for Chronic Venous Leg Ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness, safety, and economic advantages of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in treating chronic venous leg ulcers (VLU). Participants will receive standard multilayer compression dressings and will be randomly assigned to either the TWO2 therapy or a sham control group after a two-week run-in period. The intervention lasts up to 16 weeks, followed by a long-term follow-up period of 52 weeks. The study seeks to understand the impact of oxygen on wound healing in patients suffering from VLUs.

Why it matters

Who can join: the full rules

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

Where it's running

• Vascular Institute of New York
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Anil Hingorani, MD
• Study coordinator: Despina Herodotou, MRCPod, DABPMi
• Email: despi.herodotou@aotinc.net
• Phone: 1-760-431-4700

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.