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

NCT06754735 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2025-11-19

No results posted yet for this study

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)

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • AOTI Ltd.

    lead INDUSTRY

Principal Investigators

  • Mike Griffiths, DProf, DMS, CRT, FCMI · AOTI Ltd.

  • Anil Hingorani, MD

  • Wael Tawfick, MB.BCH, MRCSI. · University of Galway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2027-06-30
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06754735 on ClinicalTrials.gov