A randomised controlled study of four-layer compression versus Unna's Boot for venous ulcers.

OBJECTIVE This study set out to compare healing rates, handling properties and patient comfort of a four-layer bandage system (Profore) and Unna's Boot in the treatment of venous leg ulcers. METHOD This was a prospective randomised parallel-group trial. Patients with venous leg ulcers from four centres in Italy were randomised to receive treatment with either Unna's Boot or Profore. Time to healing was recorded for a maximum of 24 weeks. Pain was assessed using a visual analogue scale. Staff assessed ease of application, while patients rated comfort. RESULTS Data were available for 68 patients with 68 wounds. At 24 weeks complete healing was seen in 74% of the Profore group compared with 66% of the Unna's Boot group. The median time spent in the study was 50 days (range: 7-175 days), corresponding to 51 days (range: 7-175 days) for Profore patients and 49 days (range: 7-168 days) for Unna's Boot patients. There was no difference (p = 0.13) between the groups in time to closure. Overall, more Profore than Unna's Boot applications were rated as excellent. There was a significant difference, in favour of Profore, in ease of application at the final application (p = 0.013). At the initial application, there was a significant difference in bandage appearance (p = 0.04), again favouring Profore, but this was not sustained at the final application (p = 0.18). CONCLUSION Profore is as effective as Unna's Boot in the treatment of venous leg ulcers.