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.
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.
基金
supported by the National Council for Scientific and Technological Development(CNPq,grant number476454/2013-1)
the Research Support and Innovation Foundation of the State of Santa Catarina(FAPESC,grant numbers 3414/2012and FAPESC-2019TR73)
the Coordination for the Improvement of Higher Education Personnel(CAPES)
the UNISUL and UNIJUI Scientific Initiation Program(PUIC)
supported by research fellowships from CNPq(309407/2017-6).
