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

Abstract

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.

Clinical evaluation of the efficacy and safety of a medical device in various forms containing Triticum vulgare for the treatment of venous leg ulcers – a randomized pilot study

“… 29 The use of dressing placed over the ulcer prior to the application of compression to improve healing is widespread, and the number of available products is increasing. 30 , 31 However, no clear evidence-based efficacy difference exists among dressing types; therefore, new products are currently under development. The various pharmaceutical forms of the medical device evaluated in this study are intended for topical treatment of cutaneous lesions of different origin (wounds, burns, ulcers, etc).…”

Comparative effectiveness of advanced wound dressings for patients with chronic venous leg ulcers: A systematic review

“…We included 37 studies (38 publications) enrolling a total of 3,990 patients (Figure ) . Thirty‐six of 37 studies were RCTs, one was a nonrandomized trial, and another was a retrospective cohort study.…”

"Wound Bed Preparation: Standards of Care and Predictability of the Healing Time of Chronic Wounds"

“…It is highly appreciated that, to predict the outcome of recovery in individual patients, it will be necessary to use not a single marker, but the data resulting from a combination of several markers, as we proposed. Many authors have stressed the importance of training the nursing staff, designed to provide the knowledge and skills necessary to establish appropriate treatment and process protocols and forms relating to wound care [56].…”