Hydrogel Enriched With Sodium Alginate and Vitamins A and E for Diabetic Foot Ulcer

A Randomized Controlled Trial

Murilo Gustinelli Barbosa, MSN; Viviane Fernandes Carvalho, PhD; Andre Oliveira Paggiaro, PhD


Wounds. 2022;34(9):229-235. 

In This Article

Abstract and Introduction


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.


Diabetic foot ulcers are full-thickness lesions that extend from the distal skin to the malleolus, and they are a significant complication of diabetes.[1] Up to 25% of patients with diabetes experience a DFU.[2] Diabetic neuropathy increases the risk of uncontrolled recurring lesions in the lower limbs and is a risk factor for foot and leg ulceration that may necessitate amputation.[3] With an average healing time of 1 year, such ulcers are associated with poor clinical outcomes, increased morbidity and mortality, and worsening of quality of life.[4,5]

Cutaneous traumas cause physiological cellular and tissue responses in the healing process; these include infiltration of inflammatory cells, epithelialization, granular tissue formation, extracellular matrix deposition, wound contraction, and tissue maturation. In diabetic wounds, this repair response cycle is altered, with inadequate secretion of extracellular matrix proteins and the deregulation of macrophage activity. Additionally, there is an increase in fibroblast apoptosis, impaired angiogenesis, and reepithelialization.[6] Diabetes increases oxidative stress, causing chronic inflammation that damages cells that undergo senescence conversion, and as a result, become pro-inflammatory and perpetuate this phenotype in all tissues. Such cellular senescence may contribute to the chronification of ulcers, local ischemia, and an increase in bacterial load and necrotic tissue.[7]

Adequate WBP aids progression of the normal repair process in these situations.[8] Debridement is essential to WBP and allows for the removal of necrotic tissue, thus reducing the number of microorganisms, toxins, and other substances that prevent healing.[9,10] The autolytic debridement method consists of keeping the wound wet so that the cells and endogenous enzymes remove the necrotic tissue. Hydrogels are a widely used type of autolytic debridement dressing. They consist of compounds of hydrophilic polymers inside an interdimensional matrix that can create a wet environment on the wound bed, thus facilitating endogenous enzymes in the autolysis of necrotic and apoptotic tissue.[11,12]

A product that combines hydrogel with calcium alginate, oily acids, and vitamins A and E (Dersani Hidrogel; Laboratório Daudt Oliveira LTDA) is a new therapeutic option for treating a DFU. The hydrogel promotes autolytic debridement, and alginate stimulates new granulation tissue on the wound bed. Oily acids (capric acid triglycerides, lecithin, retinol palmitate, α-tocopherol) and vitamins A and E facilitate the reepithelialization process.[13] In a recent case series, amorphous hydrogel enriched with oily acids and vitamins A and E was used to treat ulcers on the lower limbs of patients with diabetes. Of the 7 patients, 2 had achieved complete healing and 5 had experienced reductions in lesion area and PUSH score.[14]

Based on those promising results, the current clinical trial was designed to evaluate the efficacy of autolytic debridement promoted by hydrogel with sodium alginate enriched with oily acid and vitamins A and E to stimulate wound bed healing in DFUs. The microscopic effects of the hydrogel in promoting collagen production and reducing inflammatory infiltrates in the wound bed were qualitatively evaluated.