Efficacy and Safety of Regulatory Vascular Polypeptides in Chronic Venous Diseases of the Lower Extremities: Results of a Randomized Placebo-Controlled Study

Objective. To evaluate the efficacy and safety of a therapeutic agent derived from regulatory polypeptides sourced from bovine vascular tissue in combination therapy for patients diagnosed with chronic venous diseases (CVD) in the lower extremities. Material and methods. This multicenter, randomized, double-blind, placebo-controlled trial involved 190 patients with CVD, randomly assigned to two groups. Group 1 received a combination of vascular polypeptides and troxerutin (n=95), while Group 2 received placebo with troxerutin (n=95). The total duration of the observation period extended to 137 days. This period included five scheduled visits: Visit 1 at the start of therapy; Visit 2 after 14±2 days of treatment; Visit 3 at the end of the treatment (35±2 days); Visit 4 30±3 days after the end of the treatment; and Visit 5 90±5 days after the end of the treatment. Efficacy was evaluated using the Venous Clinical Severity Score (VCSS), and pain and discomfort were quantified using the Visual Analog Scale (VAS). Quality-of-life outcomes were measured using the CIVIQ-20 questionnaire, and changes in malleolar circumference were recorded. Safety was assessed by the frequency and types of adverse events. Results. At Visit 4, the mean VCSS in Group 1 was 2.33±1.31, compared to 3.24±1.62 in Group 2, resulting in a mean difference of –0.92 (95% CI from –1.34 to –0.50; p<0.001), confirming the hypothesis of the efficacy of the combination therapy. At Visit 4, a clinically significant improvement in quality of life, defined as a reduction of 5 points or more on the CIVIQ-20, was observed in 93.7% of patients in Group 1, compared with 75.8% in Group 2 (p=0.0006). This effect persisted at Visit 5, with improvements noted in 92.6% in Group 1 compared to 78.9% in Group 2 (p=0.007). Additionally, a reduction of at least 1 point in pain intensity on the VAS was observed in 91.6% of patients in Group 1, compared with 74.7% in Group 2 (p=0.002). Malleolar circumference exhibited a greater reduction in Group 1 at Visit 5 (0.76±0.79 cm vs. 0.46±0.64 cm; p=0.004). No serious adverse events were reported throughout the study. Conclusions. Incorporating bovine regulatory vascular polypeptides into a combined therapeutic approach effectively alleviates symptoms of chronic venous disease and enhances quality of life while maintaining a favorable safety profile.