Clinical Efficacy of Acellular Dermal Matrix Paste in Treating Diabetic Foot Ulcers

Myungchul Lee, MD, PhD; Dongkeun Jun, MD; Hyungon Choi, MD, PhD; Jeenam Kim, MD, PhD; Donghyeok Shin, MD, PhD

Disclosures

Wounds. 2020;32(2):50-56. 

In This Article

Abstract and Introduction

Abstract

Introduction: Diabetic foot ulcers (DFUs) are slow to heal because of poor tissue vascularity and regenerative capacity, among various factors.

Objective: In this study, the authors evaluate the efficacy of applying a paste formulation of acellular dermal matrix (ADM) to DFUs.

Materials and Methods: Patients with Wagner grade 2 or 3 DFUs (N = 49) received either ADM paste (treatment group; n = 23) or conventional foam dressing (control group; n = 26). All chronic wounds were debrided and irrigated in an attempt to control infection. After paste application, mild compaction was undergone to fill ulcer cavities, and foam dressings were used to cover the surface to absorb any discharge. All DFUs were analyzed with regard to ulcer area, depth, progression, healing rate, and duration to complete healing.

Results: At the 60-day primary outcome mark, 56.52% (13/23) of the DFUs in the treatment group were healed, compared with 23.08% (6/26) of DFUs in the control group. Mean rates of wound area resolution in the treatment and control groups were 74.17% ± 30.84% and 51.87% ± 32.81%, respectively (P < .05), with mean times to heal (within 60 days) of 13.54 ± 9.18 days and 21.5 ± 11.98 days, respectively (P < .05). There were no serious adverse events in either group, and no complications related to ADM paste application.

Conclusions: The ADM paste effectively enhanced tissue regeneration, shortening ulcer duration and preventing associated complications, while eliminating the need for supplemental ulcer management procedures. The paste formulation of ADM provides a matrix for tissue ingrowth, promoting the healing of DFUs.

Introduction

Poor vascularity and inadequate tissue matrix often plague the management of diabetic ulcers, among various factors. More than 150 million people worldwide suffer from diabetes, and every patient with diabetes is at risk of developing a diabetic foot ulcer (DFU) with varying degrees, and more than 15% will actually develop such ulcers.[1] Among the diverse treatments used to manage DFUs, methods traditionally employed include rigorous dressing changes with cautious observation, debridement of necrotic tissue, infection control, and reduction of pressure on the diabetic foot.[2–4] Lower extremity revascularization is also a consideration in some instances.[5] If treatments fall short at critical times, these nonhealing, chronic wounds may lead to foot amputations and alter a patient's quality of life.[6]

Recent studies have explored more effective wound dressings and tissue engineering techniques, such as vacuum-assisted closure, adipose-derived stem cell use, and allogenic or xenogenic material applications.[4,7,8] Similarly, clinical trials have investigated the efficacy of acellular dermal matrix (ADM) in treating DFUs.[2,9] Acellular dermal matrix is a cutaneous derivative incorporating collagens, elastin, glycosaminoglycans, and hyaluronic acids as structural elements. It has been decellularized to limit immune triggers and facilitate host-cell infiltration. This matrix serves as a reservoir of growth factors, such as vascular endothelial growth factor and fibroblast growth factor, for modulating cellular responses, and its structural fortification protects chronic open wounds, preventing deeper tissues from desiccation.[2,10] Clinical studies have already documented the safety and efficacy of ADM in chronic wound healing.[9,11] In addition, paste formulations of ADM easily can be introduced into geometric or tunnel-type ulcers without damaging adjacent tissues. When combined with gelatin, micronized ADM shows semi-fluidic characteristics.

In this study, the authors evaluated the safety and efficacy of ADM paste in treating patients with DFUs. Area and depth of the wounds were monitored over time, analyzing their progression, healing rates, and durations to complete healing.

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