Economic evaluation of a randomized controlled trial of ultrasound therapy for hard-to-heal venous leg ulcers

Background: A pragmatic, multicentre randomized controlled trial (VenUS III) was conducted to determine whether low‐dose ultrasound therapy increased the healing rate of hard‐to‐heal leg ulcers. This study was a cost‐effectiveness analysis of the trial data. Methods: Cost‐effectiveness and cost–utility analyses were conducted alongside the VenUS III trial, in which patients were randomly allocated to either ultrasound treatment administered weekly for 12 weeks along with standard care, or standard care alone. The time horizon was 12 months and based on the UK National Health Service (NHS) perspective. Results: The base‐case analysis showed that ultrasound therapy added to standard care was likely to be more costly and provide no extra benefit over standard care alone. Individuals who received ultrasound treatment plus standard care took a mean of 14·7 (95 per cent confidence interval − 32·7 to 56·8) days longer to heal, had 0·009 (−0·042 to 0·024) fewer quality‐adjusted life years and had higher treatment costs by £197·88 (−35·19 to 420·32). Based on these point estimates, ultrasound therapy plus standard care for leg ulcers was dominated by standard care alone. The analysis of uncertainty showed that this treatment strategy is unlikely to be cost‐effective. Conclusion: Ultrasound treatment was not cost‐effective for hard‐to‐heal leg ulcers and should not be recommended for adoption in the NHS. Registration number: ISRCTN21175670 (http://www.controlled‐trials.com) and N0484162339 (National Research Register). © 2011 Crown copyright. Published by John Wiley & Sons, Ltd. Not cost effective