Journal of integrative medicine | 2019
Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial.
Abstract
BACKGROUND\nVenous 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.\n\n\nOBJECTIVE\nWe 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.\n\n\nDESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS\nThis 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\xa0days.\n\n\nMAIN OUTCOME MEASURES\nThe following evaluations were conducted at baseline and after 15, 30, 60 and 90\xa0days: ulcer healing score, quality of life, and serum markers of oxidative stress and antioxidant enzyme activity.\n\n\nRESULTS\nPatients (n\xa0=\xa024) with lower limb venous ulcers were randomized into two treatment groups. cFIR decreased the ulcer size on day 30 (P\xa0=\xa00.042) and 90 (P\xa0=\xa00.034) and the total ulcer healing scale scores on day 30 (P\xa0=\xa00.049) and 90 (P\xa0=\xa00.02) of the treatment, when compared to baseline. Additionally, cFIR improved tissue type (epithelial tissue) on day 60 (P\xa0=\xa00.022) when compared to baseline evaluation.\n\n\nCONCLUSION\ncFIR clinically improved ulcer healing in patients with lower limb venous ulcers.\n\n\nTRIAL REGISTRATION\nRBR-8c7xzn on ReBEC.