title: EVerT2-needling versus non-surgical debridement for the treatment of verrucae: study protocol for a single-centre randomised controlled trial.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  ISRCTN16429440.
authors.affiliation: University of Salford, School of Health Sciences, Manchester, UK.
authors.forename: Farina
authors.initials: F
authors.lastname: Hashmi
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Caroline
authors.initials: C
authors.lastname: Fairhurst
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Cockayne
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Kerry
authors.initials: K
authors.lastname: Bell
authors.affiliation: University of Salford, School of Health Sciences, Manchester, UK.
authors.forename: Michelle
authors.initials: M
authors.lastname: Cullen
authors.affiliation: University of Salford, School of Health Sciences, Manchester, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Harrison-Blount
mesh_terms: D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003646:Debridement / Q000379:methods*; D006801:Humans; D009339:Needles; D017063:Outcome Assessment, Health Care; D012107:Research Design; D012867:Skin / Q000473:pathology*; D014860:Warts / Q000628:therapy*
keywords: callus decridement; needling; plantar warts; verrucae