Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial

摘要

Background:Venous ulcer represents the most advanced stage of chronic venous insufficiency.It is an important public health problem and has a significant impact on patients’quality of life due to chronic pain,inability to work,need for hospitalization and frequent outpatient follow-up.Objective:We investigated the treatment benefits of far-infrared ceramic(cFIR),in a 90-day study of lower limb venous ulcers and looked at ulcer healing scores,quality of life,serum bio-markers of oxidative stress and antioxidant defense enzymes.Design,setting,participants and interventions:This is a randomized double-blind placebo-controlled study conducted in the Vascular Surgery Service of a hospital located in the northwest region of the State of Rio Grande do Sul,Brazil.We included patients with lower limb venous ulcers who were randomized to use either a bioceramics wrap or a placebo wrap for 90 days.Main outcome measures:The following evaluations were conducted at baseline and after 15,30,60 and90 days:ulcer healing score,quality of life,and serum markers of oxidative stress and antioxidant enzyme activity.Results:Patients(n=24)with lower limb venous ulcers were randomized into two treatment groups.cFIR decreased the ulcer size on day 30(P=0.042)and 90(P=0.034)and the total ulcer healing scale scores on day 30(P=0.049)and 90(P=0.02)of the treatment,when compared to baseline.Additionally,cFIR improved tissue type(epithelial tissue)on day 60(P=0.022)when compared to baseline evaluation.Conclusion:cFIR clinically improved ulcer healing in patients with lower limb venous ulcers.Trial registration:RBR-8c7xzn on ReBEC.