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)

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.

Original languageEnglish
Pages (from-to)495-499
Number of pages5
JournalEuropean Journal of Vascular and Endovascular Surgery
Volume39
Issue number4
DOIs
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.

Fingerprint

Dive into the research topics of 'Randomised Clinical Trial of Foam Sclerotherapy for Patients with a Venous Leg Ulcer'. Together they form a unique fingerprint.

Cite this