Jull A, Wadham A, Bullen C, Parag V, Kerse N, Waters J, et al.
BMJ (Clinical research ed.). Date of publication 2017 Nov 24;volume 359():j5157.
1. BMJ. 2017 Nov 24;359:j5157. doi: 10.1136/bmj.j5157.
Low dose aspirin as adjuvant treatment for venous leg ulceration: pragmatic,
randomised, double blind, placebo controlled trial (Aspirin4VLU).
Jull A(1)(2), Wadham A(2), Bullen C(2), Parag V(2), Kerse N(3), Waters J(4).
Author information:
(1)School of Nursing, University of Auckland, Auckland, New Zealand
a.jull@auckland.ac.nz.
(2)National Institute for Health Innovation, University of Auckland, Auckland,
New Zealand.
(3)School of Population Health, University of Auckland, Auckland, New Zealand.
(4)Adult Long Term Conditions and Community Services, Auckland District Health
Board, Auckland, New Zealand.
Objective To determine the effect of low dose aspirin on ulcer healing in
patients with venous leg ulcers.Design Pragmatic, community based, parallel
group, double blind, randomised controlled trial.Setting Five community nursing
centres in New Zealand.Participants 251 adults with venous leg ulcers who could
safely be treated with aspirin or placebo: 125 were randomised to aspirin and 126
to placebo.Interventions 150 mg oral aspirin daily or matching placebo for up to
24 weeks treatment, with compression therapy as standard background
treatment.Main outcome measures The primary outcome was time to complete healing
of the reference ulcer (largest ulcer if more than one ulcer was present).
Secondary outcomes included proportion of participants healed, change in ulcer
area, change in health related quality of life, and adverse events. Analysis was
by intention to treat.Results The median number of days to healing of the
reference ulcer was 77 in the aspirin group and 69 in the placebo group (hazard
ratio 0.85, 95% confidence interval 0.64 to 1.13, P=0.25). The number of
participants healed at the endpoint was 88 (70%) in the aspirin group and 101
(80%) in the placebo group (risk difference -9.8%, 95% confidence interval -20.4%
to 0.9%, P=0.07). Estimated change in ulcer area was 4.1 cm2 in the aspirin group
and 4.8 cm2 in the placebo group (mean difference -0.7 cm2, 95% confidence
interval -1.9 to 0.5 cm2, P=0.25). 40 adverse events occurred among 29
participants in the aspirin group and 37 adverse events among 27 participants in
the placebo group (incidence rate ratio 1.1, 95% confidence interval 0.7 to 1.7,
P=0.71).Conclusion Our findings do not support the use of low dose aspirin as
adjuvant treatment for venous leg ulcers.Trial registration ClinicalTrials.gov
NCT02158806.
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DOI: 10.1136/bmj.j5157
PMCID: PMC5701114
PMID: 29175902 [Indexed for MEDLINE]
Conflict of interest statement: Competing interests: All authors have completed
the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and
declare: no support from any organisation for the submitted work; the HRC of New
Zealand funded this trial; no other relationships or activities that could appear
to have influenced the submitted work.
