Randomised Clinical Trial of Foam Sclerotherapy for Patients with a Venous Leg Ulcer

Abstract

Objectives To assess whether routine use of foam sclerotherapy, in addition to four-layer compression bandaging, could speed up the healing of venous ulcers. Design Randomised controlled trial involving patients recruited from a nurse-led leg ulcer clinic. A total of 315 new patients were assessed, and eleven patients were identified from follow-up clinics. Methods Inclusion criteria were: patients with an active venous leg ulcer, in the presence of superficial truncal venous incompetence and without total deep venous incompetence on duplex imaging. Patients were randomised to four-layer compression bandages alone (control) or with additional foam sclerotherapy to incompetent superficial truncal veins. The primary endpoint was ulcer healing 24 weeks after randomisation. Results It was only possible to recruit 40 patients who were suitable for analysis: 22 control, 18 additional foam sclerotherapy. There was no complication from the foam treatment and at six months the target vein was occluded in 9 of 11 evaluable patients that had foam. One patient died before 24 weeks from an unrelated cause. At 24 weeks, 17 of 20 (85% - 1 died) in the control group and 12 of 13 (92%) patients with additional foam sclerotherapy had ulcer healing (P=0.72, log rank testing). Conclusion This trial failed to recruit sufficient patients for formal comparison, but foam sclerotherapy was feasible as an adjunct to compression therapy for venous ulceration. Trial registration: Eudra CT 2005-001551-38