Dressings and topical agents for arterial leg ulcers

Cathryn Broderick, Fania Pagnamenta, Rachel Forster

Research output: Contribution to journalArticlepeer-review

Abstract

Background
It is estimated that up to 1% of people in developed countries have a 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 the third 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 and patient-centred outcomes between wound dressings and topical agents.
Search methods
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases, the World Health Organization international Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 28 January 2019.
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. We included articipants with arterial leg ulcers irrespective of method of diagnosis. Trials that included participants with mixed arterio-venous disease and diabetes were eligible for inclusion if the results were presented separately. All wound dressings and topical agents were eligible for inclusion in this review. We excluded trials which did not report on at least one of the primary outcomes (time to healing, proportion completely healed, or change in ulcer area). Data collection and analysis 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. We presented the data narratively due to differences in the included trials. We used GRADE to assess the certainty of the evidence.
Main results
Two trials met the inclusion criteria. One compared 2% ketanserin ointment in polyethylene glycol (PEG) with PEG alone, twice a day in 40 participants with arterial leg ulcers for eight weeks or until healing, whichever was sooner. One compared topical application of blood derived concentrated growth factor (CGF) with standard dressing (polyurethane film or foam); both applied weekly for six weeks in 61 participants. Both were small trials with inadequate reporting of the results and were of low methodological quality. Short follow-up times (six and eight weeks) meant it would be difficult to capture sufficient healing events to allow comparisons to be made. One trial demonstrated accelerated wound healing in the ketanserin group, compared with the control group. In the trial comparing CGF with standard dressings, 66.6% (6/9) of diabetic arterial ulcers showed more than 50% decrease in ulcer size compared to 6.7% (2/30) of ulcers treated with standard dressing. Numbers of participants with diabetic arterial ulcers were only reported in the CGF group (9/31), diabetic arterial ulcer specific data were not reported separately for the standard 371C Dressings and topical agents for arterial leg ulcers 2 / 46 dressing group. We assessed this as very-low certainty evidence due to the small numbers of studies and arterial ulcer participants, inadequate reporting of methodology and data, and short follow-up period. Only one trial reported side effects (complications), stating no participant experienced these during follow-up (six weeks, lowcertainty evidence). It should also be noted that ketanserin is not licensed in all countries for use in humans. Time to ulcer healing and patient satisfaction and quality of life were not reported by either study.
Authors' conclusions
There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.
Original languageEnglish
Pages (from-to)CD001836
JournalCochrane Database of Systematic Reviews
DOIs
Publication statusPublished - 24 Jan 2020

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