Study Comparing First-Visit Foam Sclerotherapy to Scheduled Treatment in Patients with Venous Leg Ulcers Aiming to Measure Ulcer Healing Time and Quality of Life

What this Trial Is About

Researchers are evaluating the effect of first-visit foam sclerotherapy in patients with venous leg ulcers. This study compares this treatment to the current standard scheduled treatment. The goal is to see how quickly the ulcers heal, with a follow-up period of one year. The study is a multicenter randomized controlled trial led by Oulu University Hospital and includes adult patients with venous leg ulcers verified by ultrasound. Participants are randomly assigned to one of two groups. In the first-visit foam sclerotherapy group, patients receive foam sclerotherapy during their first visit, including treatment under the ulcer, and scheduled endothermal ablation when suitable. In the scheduled treatment group, patients receive standard care with scheduled foam sclerotherapy andor endothermal ablation based on vein reflux anatomy. Both groups start compression therapy immediately with class 2 thigh-high compression or the best tolerated compression. Additional treatments for insufficient veins and truncal insufficiency are provided during scheduled visits. Throughout the study, researchers monitor the time it takes for ulcers to heal, tracking this over 365 days. They also assess quality of life using EQ-5D and Wound-QOL questionnaires and measure ulcer area. Follow-up visits include evaluations of venous health and treatment effects. The total planned enrollment is 248 patients, and the study continues until March 2026. Safety and adherence to treatment are monitored during the one-year follow-up.

Finnish Venous Ulcer Study (FINNULCER Study)