Aspirin in venous leg ulcer study (ASPiVLU): study protocol for a randomised controlled trial

Table 1 Study schedule

Measurement/activity	Screening^a	Treatment period in weeks													Follow-up period
		(Weekly wound management and assessments until target ulcer healed OR 12 weeks – whichever occurs first. The 12-week visit is mandatory for all participants regardless of ulcer status.)													(from week 12 until week 24)
		Recruitment & Baseline Assessment (Day 1)	Wk 1	Wk 2^b	Wk 3^b	Wk 4^b	Wk 5^b	Wk 6^b	Wk 7^b	Wk 8^b	Wk 9^b	Wk 10^b	Wk 11^b	Wk 12	Monthly	Wk 24/end of study
Informed consent		X
Eligibility criteria	X
Recruitment & randomisation		X
Target ulcer assessment – general features		X	X	X	X	X	X	X	X	X	X	X	X	X³
Wound pain score		X	X	X	X	X	X	X	X	X	X	X	X	X³	X	X
Target ulcer assessment – size (tracing) & photo		X				X				X				X³
Medical history including demographics & medications		X
Physical examination including vital signs		X
QOL assessment (EQ-5D-5L)		X												X		X
Serum sample		X												X		X
Trial medication dispensed		X
Ulcer care education		X
Adherence to compression (or hosiery)			X	X	X	X	X	X	X	X	X	X	X	X	X	X
Adherence to trial medication			X	X	X	X	X	X	X	X	X	X	X	X	X	X
Concomitant/new medication			X	X	X	X	X	X	X	X	X	X	X	X	X	X
Adverse events including hospitalisation			X	X	X	X	X	X	X	X	X	X	X	X	X	X
Wound assessment			X	X	X	X	X	X	X	X	X	X	X	X
Ulcer prevention education			X²	X²	X²	X²	X²	X²	X²	X²	X²	X²	X²	X
Target ulcer recurrence assessment															X²	X²
Refer to wound clinic														X³	X⁴	X⁴
Reconciliation of medication																X

^aScreening to be conducted within 14 days of baseline (day 1) assessment
^bAssessment conducted only if the target ulcer unhealed
X² = if healed
X³ = if not healed
X⁴ = if ulcer has recurred (this applies to participants whose target ulcer recurs after initial healing is achieved)

ISSN: 1745-6215