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

J. L. O'Hare, J. J. Earnshaw*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

41 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)495-499
Number of pages5
JournalEuropean Journal of Vascular and Endovascular Surgery
Issue number4
Publication statusPublished - Apr 2010
Externally publishedYes

Bibliographical note

Funding Information:
The authors would like to thank Colin Davies, Rachel Elley, Nicky Kenney, Glenda Turton, Jo Waldron and Gina Woolfrey (Gloucestershire Leg Ulcer Team) for their assistance in recruitment and follow-up of patients; Kate Harvey and Vivian Cannon (Vascular Technologists) for their assistance in duplex assessment and follow-up; Donna Parkin and Julie Stevens for their participation in foam sclerotherapy treatments and follow-up; Chris Foy for help with the statistics, and Chantal Vandenbroeck who helped design the study. The funding for this study came from the Gloucester Vascular Research Trust Fund.


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