NCT06754735View on ClinicalTrials.gov

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

PHASE4RecruitingINTERVENTIONAL
Enrollment

212

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

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.

Trial Locations (1)

10016

RECRUITING

Vascular Institute of New York, New York

All Listed Sponsors
lead

AOTI Ltd.

INDUSTRY