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

Purpose This trial analyzed the effect of sub-ulcer foam sclerotherapy in patients with venous leg ulcer (VLU). Design Randomized controlled trial. Methods 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 4 weeks. The feasibility, safety, and complications of the sub-ulcer foam sclerotherapy were recorded. Results Of 23 patients included, 12 were randomized to study group and 11 to control group. Preoperatively, the average ulcer areas were 5.8 cm 2 in both groups. At 4 weeks, the average reductions in ulcer areas were 4.0 cm 2 (SD 3.1) in the study group (95% CI 2.0 to 5.9, p = .001) and 2.0 cm 2 (SD 3.1) in the control group (95% CI: −0.1 to 4.1, p = .051). No differences in complications were recorded. Conclusions 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.