EVerT2—needling versus non-surgical debridement for the treatment of verrucae : study protocol for a single centre
randomised controlled trial

Hashmi, F; Torgerson, D; Fairhurst, C; Cockayne, S; Bell, K; Cullen, M; Harrison-Blount, MJ

Abstract

Introduction: Verrucae are extremely common, and are experienced by most people at some time during their lives. Although most verrucae will spontaneously disappear without treatment, many patients seek treatment, often because they have persisted for many years, are unsightly or painful or prevent them from doing sports or other activities. There are many different treatments available; including the Falknor’s needling procedure. To date, there has only been one small trial evaluating the clinical effectiveness of this treatment and no health economic analysis has been undertaken. The Effective Verruca Treatments (EVerT2) trial aims to evaluate the clinical and cost-effectiveness of the
needling procedure for the treatment of verrucae.
Methods and analysis: This single-centre randomised controlled trial will recruit 58 participants (aged 18 years and over with a plantar verruca) from Salford Podiatry Clinic patient lists and the surrounding area. If the participant presents with multiple verrucae, an ‘index’ verruca (largest and thickest lesion) will be identified and patients will be randomised 1:1 to the intervention group to receive the needling treatment or the control group to have the callus overlying the verruca debrided. The primary outcome is complete clearance of the index verruca at 12 weeks after randomisation. Secondary outcomes include clearance and recurrence of the treated verruca, clearance of all verrucae, number of verrucae remaining, change in size of the index verruca, pain, and participant satisfaction. A cost-effectiveness analysis of the needling versus callus debridement will be carried out from the perspective of health services over a time horizon of 12 weeks.
Ethics and dissemination: Ethical approval has been obtained from the University of Salford, Department of Health Sciences Ethical Approval Committee (HSCR15/24) and the University of York, Department of Health Sciences Research Governance Committee (HSRGC/2014/98/B). Findings will be disseminated through publication and conference presentations.
Trial registration number: ISRCTN16429440.

Citation

randomised controlled trial. BMJ Open, 5(11), e009406. https://doi.org/10.1136/bmjopen-2015-009406

• Journal Article Type: Article
• Acceptance Date: Oct 29, 2015
• Publication Date: Nov 24, 2015
• Deposit Date: Nov 30, 2015
• Publicly Available Date: Apr 5, 2016
• Journal: BMJ Open
• Publisher: BMJ Publishing Group
• Volume: 5
• Issue: 11
• Pages: e009406
• DOI: https://doi.org/10.1136/bmjopen-2015-009406
• Publisher URL: http://dx.doi.org/10.1136/bmjopen-2015-009406
• Related Public URLs: http://bmjopen.bmj.com/