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.