Enhanced healing and anti-inflammatory effects of a carbohydrate polymer with zinc oxide in patients with chronic venous leg ulcers: preliminary results

Abstract

Introduction: Insufficient wound healing related to chronic inflammation of chronic venous leg ulcers (CVUs) represents an important public health problem. The aim of this study was to evaluate the effects of a carbohydrate polymer with zinc oxide therapy on CVUs.

Material and methods: Forty patients with CVUs were recruited for this study and were divided into a study group and control group. Patients In the study group were instructed to use venous compression treatment andtopical carbohydrate polymer with zinc oxide twice daily, while patients In the control group were treated with only venous compression treatment. All patients were followed up for 8 weeks. Peripheral blood samples and biosy tissue specimens were obtained at the initiation of treatment and after 8 weeks to assess serum levels of inflammatory cytokines as well as the percentage of leukocytes, T-helper cells, cytotoxic-T cells, macrophages and endothelial cells in the biopsy tissue using flow cytometry.

Results: A significantly greater reduction in the mean percentage ulcer area from baseline to eight weeks was observed in the study group (up to 40% for large ulcers). Furthermore, the patients in the study group had reduced systemic levels of the pro-inflammatory cytokines IL-8 (p = 0.0028) and IL-6 (p = 0.0302), fewer total CD45+ cells (p = 0.0038) and more CD31+ cells (p = 0.045) present in ulcer biopsies compared to the control group.

Conclusions: The carbohydrate polymer with zinc oxide treatment with venous compression enhances healing of CVUs and improves quality of life due, in part, to its anti-inflammatory properties.

Keywords: carbohydrate polymer with zinc oxide; chronic venous leg ulcers; inflammation.

Figure 1

Rates of reduction in the mean surface areas of the ulcers of both groups

Figure 2

Levels of inflammatory cytokines in the sera of patients with CVUs and treated with a carbohydrate polymer with zinc oxide. The levels of cytokines in the sera of patients treated with compression (control group, n = 16) or a carbohydrate polymer with zinc oxide with venous compression (study group, n = 19) for 8 weeks were measured using a BD Human Inflammation CBA Kit. The data were analyzed using Student’s t-test with GraphPad Prism software (GraphPad Software, Inc.). Differences with a p-value equal to or below 0.05 were considered statistically significant

Figure 3

Analysis of cell subpopulations present in biopsies from patients with CVUs after both treatments. We analyzed the different cell subpopulations in the biopsy tissue specimens using flow cytometry. The number of total leukocytes (CD45+) (A), T helper lymphocytes (CD45+, CD3+, CD4+) (levels shown as the percentage of CD4+ cells) (B), T cytotoxic lymphocytes (CD45+, CD3+ and CD8+) (levels shown as the percentage of CD8+ cells) (C), macrophages (levels shown as the percentage of CD34+ cells) (D) and endothelial cells (levels shown as the percentage of CD31+ cells) (E) from patients treated with compression (control group, n = 13) or carbohydrate polymer with zinc oxide with venous compression (study group, n = 14). The analysis was performed before and after 8 weeks of treatment for each group. The data were analyzed using a non-parametric t test and a Wilcoxon signed-rank test using GraphPad Prism software (GraphPad Software, Inc.). Differences with a p-value equal to or below 0.05 were considered statistically significant