Sub-ulcer foam sclerotherapy in patients with venous ulceration: A randomized controlled trial.

Abstract

This trial analyzed the effect of sub-ulcer foam sclerotherapy in patients with venous leg ulcer (VLU). Randomized controlled trial. This trial recruited patients with VLUs to receive either sub-ulcer foam sclerotherapy and compression therapy (study group) or compression therapy only (control group). The primary outcome of this study was the change in the venous ulcer area at 4weeks. The feasibility, safety, and complications of the sub-ulcer foam sclerotherapy were recorded. Of 23 patients included, 12 were randomized to study group and 11 to control group. Preoperatively, the average ulcer areas were 5.8cm2 in both groups. At 4weeks, the average reductions in ulcer areas were 4.0cm2 (SD 3.1) in the study group (95% CI 2.0 to 5.9, p = .001) and 2.0cm2 (SD 3.1) in the control group (95% CI: -0.1 to 4.1, p = .051). No differences in complications were recorded. At 1-month sub-ulcer foam sclerotherapy and compression therapy reduced the ulcer area statistically significantly, whereas compression therapy alone did not. Sub-ulcer foam sclerotherapy could be a good addition to superficial venous insufficiency treatment in patients with VLU.ClinicalTrials.gov identifier NCT03795064.