Wound healing in patients with venous leg ulcer: A prospective, multicentre observational cohort study.

This pragmatic observational cohort study is a prospective, multicentre observational cohort study that has been designed to follow patients with a venous leg ulcer who are deemed ineligible when screened for the ASPiVLU (ASPirin in Venous Leg Ulcer) study (ACTRN12614000293662). This observational study will evaluate wound healing within 12 weeks from the baseline screening visit (primary outcome) and examine factors related to ulcer healing and recurrence within 24 weeks (secondary outcome). Potential participants will be recruited by site investigators from participating ASPiVLU outpatient wound clinics in Victoria who are already screening for ASPiVLU Study. All consecutive patients screened for the ASPiVLU clinical trial will be offered observational cohort study participation if ineligible or unwilling to participate in the ASPiVLU clinical trial. Eligibility will be confirmed by Monash University research staff in consultation with a clinical consultant at each site. Consenting patients will be followed for 24 weeks from the date of consent. A questionnaire will be given to the patient for completion at the baseline visit. Subsequent questionnaires will be mailed to the patient at 12 and 24 weeks from screen visit and followed up by phone if not returned within 2 weeks. Information will also be collected from the patient’s medical record. Patients who are unwilling or unable to complete questionnaires will have information collected only from their medical record at Baseline and 24 weeks.