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

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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. Declaration of interest: This study was funded by Smith and Nephew.

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