Evaluating Cyclical Topical Wound Oxygen Therapy with Compression Dressings for Healing Chronic Venous Leg Ulcers in Adults

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.

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