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Dressings and topical agents for arterial leg ulcers. BACKGROUND: It is estimated that up to 1% of people in high-income countries suffer 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 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, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature and Allied and Complementary Medicine 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 participants 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 they presented results separately for the different groups. 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. Review authors resolved any disagreements 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, used twice a day by 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 by 61 participants with non-healing ulcers (venous, diabetic arterial, neuropathic, traumatic, or vasculitic). Both trials were small, reported results inadequately, 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 us to make comparisons between treatments. One trial demonstrated accelerated wound healing in the ketanserin group compared with the control group. In the trial that compared CGF with standard dressings, the number of participants with diabetic arterial ulcers were only reported in the CGF group (9/31), and the number of participants with diabetic arterial ulcers and their data were not reported separately for the standard dressing group. In the CGF group, 66.6% (6/9) of diabetic arterial ulcers showed more than a 50% decrease in ulcer size compared to 6.7% (2/30) of non-healing ulcers treated with standard dressing. We assessed this as very-low certainty evidence due to the small number 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 that no participant experienced these during follow-up (six weeks, low-certainty evidence). It should also be noted that ketanserin is not licensed in all countries for use in humans. Neither study reported time to ulcer healing, patient satisfaction or quality of life. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.

Dressings and topical agents for arterial leg ulcers. 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.