Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06754735

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

Led by AOTI Ltd. · Updated on 2025-11-19

212

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy, safety, and economic benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in treating chronic venous leg ulcers (VLU). These ulcers are caused by chronic venous insufficiency and affect about 2% of the global population, with many developing into long-lasting wounds. The trial addresses the high burden VLUs place on patients, caregivers, and healthcare systems, aiming to improve healing outcomes and quality of life by comparing TWO2 therapy with standard care. Participants will use standard multilayer compression dressings combined with either the active TWO2 device or a sham device that does not deliver oxygen or compression. Both groups will apply the device for at least 120 minutes a day, five times a week, during a treatment phase lasting up to 16 weeks. This is preceded by a 2-week run-in period with standard care. After the treatment phase, a long-term follow-up period of 52 weeks will monitor wound healing and recurrence. Throughout the study, participants will attend bi-weekly clinic visits to assess wound progress, safety, and treatment adherence. Researchers will measure wound closure rates, pain levels, infection elimination, quality of life, and adverse events up to 52 weeks. The total time commitment for participants is about one year, including treatment and follow-up, with ongoing clinical care maintained alongside study participation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older able to provide written informed consent
  • Chronic venous leg ulcer below the knee at or above the malleolus due to venous disease
  • Venous reflux of at least 500 milliseconds in superficial veins or 1 second in deep veins, or venous mapping after vascular intervention
  • Venous leg ulcer size between 1.5 cm2 and 50 cm2 after debridement at screening
  • Cluster wounds combined area must be 50 cm2 or less
  • Current ulcer present for at least 6 weeks but no more than 5 years prior to study entry
  • Treated with conventional compression dressing of at least 30 mmHg for 6 weeks or more before screening
  • Adequate blood flow to the limb shown by specific tests (ABPI 0.75-1.24, TcpO2 > 30 mmHg, or other measures)
  • Wound size reduction of 30% or less during 2-week run-in period
  • Willing and able to participate in study visits and follow-ups
  • Signed informed consent form before screening procedures
Not Eligible

You will not qualify if you...

  • Allergy to study treatments or intolerance to multilayer compression therapy
  • Acute thrombophlebitis or deep vein thrombosis within 3 months before study entry
  • Scheduled for venous ablation or less than 30 days post ablation
  • Surgery within 3 months before study entry (abdominal, gynecological, hip, or knee replacement)
  • Wounds from unclear causes or with inflammatory ulceration conditions like lupus or vasculitis
  • Evidence of bone infection (osteomyelitis) in affected limb
  • Ulcer exposing bone, muscle, or tendon
  • Severe or uncontrolled wound infection requiring hospitalization or surgery
  • Body mass index over 45
  • Uncontrolled diabetes with HbA1c over 12% within 60 days before screening
  • Kidney dialysis or very low kidney function (EGFR less than 30 mg/dl)
  • Severe heart failure (NYHA Class IV)
  • Recent arterial surgery on affected limb within 30 days
  • Use of medications interfering with the study treatment (e.g., high-dose steroids, immunosuppressants)
  • Active cancer treatment
  • Radiation history at ulcer site
  • Growth factor therapy within 14 days before screening
  • Participation in another investigational trial within 4 weeks prior to study
  • Pregnancy or breastfeeding at time of treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 16 weeks

Participants use the Topical Wound Oxygen or Sham Control device at home for a minimum of 120 minutes a day, 5 times a week over multilayered compression dressings and a wound contact layer to treat chronic venous leg ulcers.

Bi-weekly clinic visits for wound assessment and safety monitoring

Follow-up

Duration - Up to 36 weeks

Participants receive standard care according to their clinician's recommendation and are observed for wound healing, recurrence, and safety outcomes after the treatment phase ends.

Visits at weeks 20, 26, and 52 for wound monitoring and safety assessments

Trial Site Locations

Total: 1 location

1

Vascular Institute of New York

New York, New York, United States, 10016

Actively Recruiting

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Research Team

D

Despina Herodotou, MRCPod, DABPMi

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study.

Robert G Frykberg, Peter J Franks, Michael Edmonds...

https://pubmed.ncbi.nlm.nih.gov/31619393

Technical and clinical outcome of topical wound oxygen in comparison to conventional compression dressings in the management of refractory nonhealing venous ulcers.

Wael A Tawfick, Sherif Sultan

https://pubmed.ncbi.nlm.nih.gov/23223182