People with blood circulation problems in their legs can develop leg ulcers. The majority of ulcers result from poor blood flow in the veins and are treated by compression. Arterial leg ulcers occur because of poor blood supply to the legs when there is a block in a leg artery or narrowing of the arteries (atherosclerosis). Without treatment of the underlying poor arterial blood supply, ulcers take a long time to heal or may never heal. These ulcers are treated by covering them with dressings, or using creams or ointments (topical agents), or both to promote healing and protect the ulcers from infection. A variety of types of dressings can be used depending on the overall aim of the treatment. The intention is to select dressings to reduce ulcer pain, manage exudate if present (the fluid that can leak from these ulcers) and promote healing.
Study characteristics and key results
One trial was included in the review, which involved a total of 40 people with arterial leg ulcers who were randomised to either 2% ketanserin ointment in polyethylene glycol (PEG) or the vehicle (PEG) alone, administered twice a day over eight weeks. The study reported accelerated healing in the ketanserin group, when compared with vehicle alone. However, as there were only a small number of participants included with arterial disease, there were very little data reported and the follow-up period was short, making it impossible to determine whether there was any difference in the number of ulcers healed. There is therefore insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers. It should also be noted that ketanserin is not licensed in all countries for use in humans.
Quality of the evidence
The overall quality of the evidence was low with a single small included study which had 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 methodological quality of the study was rated as low because the authors of the study did not thoroughly describe the methods of the study, including how the participants were chosen and randomised, making the risk of bias unclear.
There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.
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.
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.
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).
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.
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.
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.