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

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 and 90 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.

Antioxidant Effect of Far Infrared Radiation Produced by Bioceramics in Individuals with Intermittent Claudication: A Randomized, Controlled Pilot Study.

BACKGROUND: Biomedical research has recently incorporated bioceramics applications into new health care approaches. OBJECTIVE: This study evaluated the effect of far infrared-emitting bioceramics wraps in the treatment of intermittent claudication. METHODS: This is a randomized double-blind placebo-controlled pilot study. Thirty-five patients met the criteria and were randomized into either control (placebo wraps) or bioceramics group (far infrared emitting-ceramics wraps) and assessed over a 90-day period for the following outcomes: six-minute walk test (6MWT), ankle-brachial index (ABI), Flow-mediated arterial dilation (FMD), quality of life and claudication. Oxidative stress and inflammatory biomarkers were measured in plasma of patients. RESULTS: Intervention induced a decrease in oxidative stress, with significant lower levels of reactive substances to thiobarbituric acid (TBARS), as well as increase in superoxide dismutase and catalase enzyme activities. There was an increase in the environment subscale of the quality of life questionnaire. No statistically significant differences were found in the inflammatory cytokines, 6MWT, ABI and FMV evaluations. CONCLUSIONS: In Sum, FIR treatment improved oxidative stress profile and quality-of-life of patients with intermittent claudication. The study was registered into the ensaiosclinicos.gov.br (Registro Brasileiro de Ensaios Clínicos [ReBEC]) (RBR-7nr6sy register number).