Hydrogel enriched with sodium alginate and vitamins A and E for diabetic foot ulcer: a randomized controlled trial.

INTRODUCTION

Diabetic foot ulcers usually are hard to heal, and amputation is sometimes necessary. Wound bed preparation helps promote the normal healing process, and debridement is fundamental to improving the wound microenvironment. Hydrogel enriched with sodium alginate and vitamins A and E is a new treatment that can aid in debridement and WBP.

OBJECTIVE

This study evaluates the efficacy of the autolytic debridement promoted by hydrogel in the healing of DFU.

MATERIALS AND METHODS

This was a single-blind randomized controlled trial with a 12-week follow-up period. Twenty-six patients were randomized into either the control group (cleaning and a simple dressing) or the experimental group (hydrogel treatment). Nineteen patients completed the trial. The wound area, healing, and wound severity classification based on PUSH were evaluated, and microscopic evaluation of the presence of inflammatory infiltrate and collagen production was performed.

RESULTS

The average patient age, duration of the open wound, and presence of diabetes were similar between the groups. The initial wound area was larger in the experimental group than in the control group, however. No statistically significant differences were found in any of the outcomes (lesion area and PUSH subscores) between the groups. Histological analysis demonstrated a reduction in the inflammatory infiltrate in the experimental group; however, there was no increase in collagen production.

CONCLUSIONS

The use of enriched hydrogel was found to be of no benefit compared with conventional dressings in the management of DFU.