Clinical and economic analysis on compression treatment of venous leg ulcers: clinical trial protocol VENOS

Abstract

Background Compression therapy has been considered as the gold standard in the treatment for venous ulcer healing. However, there is not sufficient evidence about the effectiveness and economic analysis of different compression therapies. Aim To compare the effects and perform an economic analysis of the monolayer high-compression elastic bandage and Unna’s boot on venous ulcer healing in patients treated at primary healthcare services. Design and methods A blinded randomised clinical trial with a sample consisting in 100 venous ulcers in patients monitored at primary healthcare services assessing the effect of compression therapies on VEnous ulcer and Nursing OutcomeS (VENOS). Group A will receive a monolayer high-compression elastic bandage and Group B Unna’s boot. The compression therapies will be applied weekly by nurses until venous ulcer healing is completed or until the 26th week. A blinded evaluator will assess the wounds by an instrument based on the Nursing Outcomes Classification (NOC) and planimetry on the first day and in the following weeks. The Short Form 6 Dimension (SF-6D) questionnaire will be applied in the first and last assessment. Discussion This study will provide knowledge about the effectiveness and economic analysis of using compression therapies in the management of venous ulcers in order to expand evidence that can exert an impact on the patients’ quality of life, improving the quality of professional practice, and help managers direct resources. Trial registration NCT04703569 (ClinicalTrials.gov).