The quality of evidence is downgraded by study limitations (unclear allocation concealment and blinding), by indirectness (differences between the outcomes of interest and those reported), and by imprecise results (few patients and outcome events).
A Cochrane review [Abstract] 1 included 2 studies with a total of 49 subjects with arterial leg ulcers. One study compared 2% ketanserin ointment in polyethylene glycol (PEG) with vehicle (PEG) alone, used twice a day by 40 participants, for 8 weeks or until healing, whichever was sooner. The study demonstrated increased wound healing in the ketanserin group compared with the control group. The other study compared topical application of blood-derived concentrated growth factor (CGF) with standard dressing (polyurethane film or foam) applied weekly for 6 weeks by 61 participants with non-healing ulcers (venous, diabetic arterial, neuropathic, traumatic, or vasculitic). Wound reduction of at least 50% surface and volume of lesion was achieved in 19/31 (61.3%) of the CGF group, compared to 2/30 (6.7%) of the standard dressing control group. In the CGF group, 9 participants had arterial diabetic ulcers, and 6 of them (66.6%) showed at least a 50% reduction in ulcer size. It was not possible to make a direct comparison with the appropriate control group because the study did not report subgroup data for diabetic arterial ulcers within the standard dressing group. Neither study reported time to ulcer healing, patient satisfaction or quality of life.
Ketanserin is not licensed in all countries for use in humans.
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