title: Aspirin in venous leg ulcer study (ASPiVLU): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Venous leg ulceration is a common and costly problem that is expected to worsen as the population ages. Current treatment is compression therapy; however, up to 50 % of ulcers remain unhealed after 2 years, and ulcer recurrence is common. New treatments are needed to address those wounds that are more challenging to heal. Targeting the inflammatory processes present in venous ulcers is a possible strategy. Limited evidence suggests that a daily dose of aspirin may be an effective adjunct to aid ulcer healing and reduce recurrence. The Aspirin in Venous Leg Ulcer study (ASPiVLU) will investigate whether 300-mg oral doses of aspirin improve time to healing.
  
  
  METHODS
  This randomised, double-blinded, multicentre, placebo-controlled, clinical trial will recruit participants with venous leg ulcers from community settings and hospital outpatient wound clinics across Australia. Two hundred sixty-eight participants with venous leg ulcers will be randomised to receive either aspirin or placebo, in addition to compression therapy, for 24 weeks. The primary outcome is time to healing within 12 weeks. Secondary outcomes are ulcer recurrence, wound pain, quality of life and wellbeing, adherence to study medication, adherence to compression therapy, serum inflammatory markers, hospitalisations, and adverse events at 24 weeks.
  
  
  CONCLUSIONS
  The ASPiVLU trial will investigate the efficacy and safety of aspirin as an adjunct to compression therapy to treat venous leg ulcers. Study completion is anticipated to occur in December 2018.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry, ACTRN12614000293662.
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia. carolina.weller@monash.edu.|Faculty of Medicine, Nursing and Health Sciences, School of Public Health & Preventive Medicine, The Alfred Centre, 99 Commercial Road, Melbourne, 3004, Australia. carolina.weller@monash.edu.
authors.forename: Carolina D
authors.initials: CD
authors.lastname: Weller
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.
authors.forename: Anna
authors.initials: A
authors.lastname: Barker
authors.affiliation: School of Medical Sciences, RMIT University, Bundoora, VIC, 3083, Australia.
authors.forename: Ian
authors.initials: I
authors.lastname: Darby
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.
authors.forename: Terrence
authors.initials: T
authors.lastname: Haines
authors.affiliation: Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Underwood
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Ward
authors.affiliation: Private Practice Clinic, Prince Charles Hospital, Chermside, QLD 4032, Australia.
authors.forename: Pat
authors.initials: P
authors.lastname: Aldons
authors.affiliation: Chronic Wound Clinic, Caulfield Hospital, Caulfield, VIC, 3162, Australia.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Dapiran
authors.affiliation: Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.
authors.forename: Jason J
authors.initials: JJ
authors.lastname: Madan
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.
authors.forename: Paula
authors.initials: P
authors.lastname: Loveland
authors.affiliation: School of Medicine, University of Tasmania, Hobart, TAS 7000, Australia.
authors.forename: Sankar
authors.initials: S
authors.lastname: Sinha
authors.affiliation: Westmead Clinical School, Westmead Hospital, Westmead, NSW 2006, Australia.
authors.forename: Mauro
authors.initials: M
authors.lastname: Vicaretti
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.
authors.forename: Rory
authors.initials: R
authors.lastname: Wolfe
authors.affiliation: Aged Care Services, Heidelberg Repatriation Hospital, Heidelberg West, VIC, 3081, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Woodward
authors.affiliation: Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.
authors.forename: John
authors.initials: J
authors.lastname: McNeil
mesh_terms: D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D001315:Australia; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D006801:Humans; D055118:Medication Adherence; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D012008:Recurrence; D012107:Research Design; D053828:Stockings, Compression; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D016861:Cyclooxygenase Inhibitors; D010975:Platelet Aggregation Inhibitors; D001241:Aspirin
keywords: Aspirin; Compression; Healing; Venous leg ulcers