title: Low-dose aspirin as an adjuvant treatment for venous leg ulceration: study protocol for a randomized controlled trial (Aspirin4VLU).
abstract: OBJECTIVE
  The aim of this study was to determine the effect of low-dose aspirin on venous leg ulcer healing when used in addition to compression.
  
  
  BACKGROUND
  The mainstay of treatment for venous leg ulcers is compression therapy and there are few adjuvant treatments to accelerate healing.
  
  
  METHODS
  Pragmatic, community-based, double-blind, randomized trial.
  
  
  METHODS
  Participants with venous leg ulcers will receive either 150 mg aspirin or placebo daily for up to 24 weeks. Participants will receive background treatment with compression therapy (system of choice guided by participant and/or clinical preference) delivered through district nursing services. The primary outcome will be time-to-healing. Secondary outcomes will include proportion healed at 24 weeks, change in ulcer area, change in health-related quality of life, adherence, efficacy of blinding and adverse events. The trial was funded in June 2014.
  
  
  CONCLUSIONS
  The trial commenced in March 2015 and is successfully recruiting. The trial is one of three trials that will contribute to an individual participant data meta-analysis to be undertaken at the York Trials Centre.
  
  
  BACKGROUND
  Registered 5 June 2014 ClinicalTrials.gov NCT02158806. Protocol version 1·1, 14 April 2015.
authors.affiliation: School of Nursing, University of Auckland, New Zealand.|National Institute for Health Innovation, University of Auckland, New Zealand.
authors.forename: Andrew
authors.initials: A
authors.lastname: Jull
authors.affiliation: National Institute for Health Innovation, University of Auckland, New Zealand.
authors.forename: Angela
authors.initials: A
authors.lastname: Wadham
authors.affiliation: National Institute for Health Innovation, University of Auckland, New Zealand.
authors.forename: Chris
authors.initials: C
authors.lastname: Bullen
authors.affiliation: National Institute for Health Innovation, University of Auckland, New Zealand.
authors.forename: Varsha
authors.initials: V
authors.lastname: Parag
authors.affiliation: School of Population Health, University of Auckland, New Zealand.
authors.forename: Ngaire
authors.initials: N
authors.lastname: Kerse
authors.affiliation: Auckland District Health Board, New Zealand.
authors.forename: Jill
authors.initials: J
authors.lastname: Waters
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000627:therapeutic use*; D058128:Compression Bandages; D003362:Cost-Benefit Analysis; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007871:Leg Ulcer / Q000188:drug therapy* / Q000451:nursing*; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D013997:Time Factors; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000188:drug therapy* / Q000451:nursing*; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D001241:Aspirin
keywords: aspirin; community nursing; protocol; randomized controlled trial; venous leg ulcer