A new protocol for the treatment of the chronic venous ulcers of the lower limb.

Venous leg ulcer is a pathological condition afflicting prevalently elderly patients, which has been found to have a major impact on individuals' health and social aspects of quality of life. Actually, the best practice treatment is recommended to include wound dressing and multilayer compression therapy. In this study, we have tested the effectiveness and safety of Vulnamin(®), a novel dressing in the form of a metal cellulose gel containing the amino acids glycine, L: -lysine, L: -proline, L: -leucine, and hyaluronic acid, and elastic compressive bandages in the treatment of chronic venous ulcers of the lower limbs. The study has been conducted in two groups of patients, one treated with Vulnamin(®) plus Ca-alginate (ulcer duration = 25.4 ± 6.2 weeks; mean baseline ulcer area = 13.9 ± 4.5 cm(2)) and a control group treated with Ca-alginate alone (ulcer duration = 23.4 ± 4.2 weeks; mean baseline ulcer area = 15.1 ± 4.7 cm(2)). Results have shown that after 70 days of treatment patients significantly ameliorate their pathological condition if they are treated with Vulnamin(®), as compared with patients treated with Ca-alginate alone. In fact, at the end of the treatment, complete healing closure was 61% in the group treated with Vulnamin(®) and, respectively, 27% in the control group. Moreover, ulcer areas showed a significant reduction in patients treated with Vulnamin(®) (mean ulcer area = 3.04 ± 0.8 cm(2)), as compared with controls (mean ulcer area = 10.96 ± 3.8 cm(2)). Overall, the results of this study indicate that Vulnamin(®) together with elastocompression is safe and more effective than standard dressing together with elastocompression in inducing a faster healing in chronic venous ulcers of the lower limb.

RCT Entities:   Population Interventions Outcomes