Forster R, Pagnamenta F, et al.
The Cochrane database of systematic reviews. Date of publication 2015 Jun 29;volume (6):CD001836.
1. Cochrane Database Syst Rev. 2015 Jun 29;(6):CD001836. doi:
10.1002/14651858.CD001836.pub3.
Dressings and topical agents for arterial leg ulcers.
Forster R(1), Pagnamenta F.
Author information:
(1)Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK,
EH8 9AG.
Update in
Cochrane Database Syst Rev. 2020 Jan 20;1:CD001836.
Update of
Cochrane Database Syst Rev. 2007;(1):CD001836.
BACKGROUND: It is estimated that people in industrialised countries have a 1%
chance of suffering from a leg ulcer at some time in their life. The majority of
leg ulcers are associated with circulation problems; poor blood return in the
veins causes venous ulcers (around 70% of ulcers) and poor blood supply to the
legs causes arterial ulcers (around 22% of ulcers). Treatment of arterial leg
ulcers is directed towards correcting the poor arterial blood supply, for example
by correcting arterial blockages (either surgically or pharmaceutically). If the
blood supply has been restored, these arterial ulcers can heal following
principles of good wound care. Dressings and topical agents make up a part of
good wound care for arterial ulcers but there are many products available and it
is unclear what impact these have on ulcer healing. This is an update of a review
first published in 2003.
OBJECTIVES: To determine whether topical agents and wound dressings affect
healing in arterial ulcers. To compare healing rates, patient-centred outcomes
and costs between wound dressings and topical agents.
SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group
Trials Search Co-ordinator searched the Specialised Register (last searched
November 2014) and The Cochrane Central Register of Controlled Trials (CENTRAL)
(the Cochrane Library) (2014, Issue 10).
SELECTION CRITERIA: Randomised controlled trials (RCTs), or controlled clinical
trials (CCTs) evaluating dressings and topical agents in the treatment of
arterial leg ulcers were eligible for inclusion. The participants had to have
ulcers that were described as arterial, and the time to healing, proportion
completely healed, or rate of reduction in ulcer area had to be reported. All
wound dressings and topical agents were eligible for inclusion in this review.
DATA COLLECTION AND ANALYSIS: The two review authors independently extracted
information on the participants' characteristics, the interventions, and outcomes
using a standardised data extraction form. Disagreements between the review
authors were resolved through discussion.
MAIN RESULTS: One trial met the inclusion criteria, which was a small trial that
compared 2% ketanserin ointment in polyethylene glycol (PEG) with vehicle alone
(PEG) control, changed twice a day in 40 participants with arterial leg ulcers.
The overall quality of the evidence was low with a single small included study
which showed inadequate reporting of the results and had too short a follow-up
time (eight weeks) to be able to capture sufficient healing events to allow
comparisons to be made. In addition, the study was of low methodological quality.
The majority of the 'risk of bias' domains received an 'unclear' risk rating as
very little information was provided in the text on the methods of the study. The
trial demonstrated increased wound healing in the ketanserin group, compared with
the control group, but the trial was too small and had too short a follow-up
period (eight weeks) to be able to determine whether there was any difference in
healing rates. It should also be noted that ketanserin is not licensed in all
countries for use in humans.
AUTHORS' CONCLUSIONS: There is insufficient evidence to determine whether the
choice of topical agent or dressing affects the healing of arterial leg ulcers.
DOI: 10.1002/14651858.CD001836.pub3
PMID: 26121115 [Indexed for MEDLINE]