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

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Gerli E G Herr 1, Fábio Goulart da Silva 1, Francisco José Cidral-Filho 2, Fabricia Petronilho 3, Lucinéia Gainski Danielski 3, Mariana Pereira de Souza Goldim 3, Afonso Shiguemi Inoue Salgado 4, Franciane Bobinski 2, Daniel Fernandes Martins 5, Eliane R Winkelmann

Main idea: far-infrared ceramic clinically improved ulcer healing in patients with lower limb venous ulcers.

Abstract

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 biomarkers 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 and 90 days: ulcer healing score, quality of life, and serum markers of oxidative stress and antioxidant enzyme activity.

Results: Patients with lower limb venous ulcers were randomized into two treatment groups. cFIR decreased the ulcer size on day 30 and 90 and the total ulcer healing scale scores on day 30 and 90 of the treatment, when compared to baseline. Additionally, cFIR improved tissue type (epithelial tissue) on day 60 when compared to baseline evaluation.

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