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

Abstract

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.