The safety and efficacy of Sclerosing foam on treating venous leg ulcers: Protocol for systematic review and meta-analysis.

BACKGROUND: Venous leg ulcers (VLUs) are common throughout the world, which seriously affects the patient's work and life. Relevant researches suggested that sclerosing foam (SF) has potential benefits for VLUs. However, there is no consistent conclusion. The purpose of our study is to assess whether SF is effective and safe for VLUs.

METHODS: Relevant clinical randomized controlled trials will be obtained from a search of 8 databases (with no language restrictions) from their inception to May 2020: PubMed, the Cochrane Library, EMBASE, Web of Science, China National Knowledge Infrastructure Database, Wanfang Database, China Science and Technology Journal Database, and Chinese Biological Medicine. Data will be analyzed using RevMan 5.3 after literature screening and data extraction according to predefined inclusion and exclusion criteria. Cochrane Collaboration Risk of bias Tool will be applied in evaluating the quality of enrolled articles. The primary outcome is Closure of venous leg ulcers, ulcer healing rate, adverse events related to SF. The secondary outcomes include ulcer healing time, ulcer recurrence rate, pain. Risk ratio will be used for categorical data; mean differences will be used for measurement data. Where possible and appropriate, meta-analysis will be performed for each outcome.

RESULTS: To clarify whether Sclerosing foam can be safe and efficient on treating venous leg ulcers.

CONCLUSION: Our review will provide useful information to judge whether Sclerosing Foam is an effective and safe intervention for patients with venous leg ulcers.