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

Materials and Methods

The authors retrospectively reviewed the medical records of patients with DFUs. Inclusion criteria involved patients with DFUs that were treated between August 2015 and January 2018. They received wound management using either ADM paste or conventional foam dressing method. The study protocol conformed to the ethical guidelines of the Declaration of Helsinki, as reflected in the approval by the Konkuk University School of Medicine (Seoul, South Korea) human research review committee. The study was approved by the Institutional Review Board of Konkuk University School of Medicine (KUH 1280110).

The authors comprehensively reviewed data from 86 consecutive patients who were potential study candidates. Patients afflicted with chronic DFUs characterized as Wagner grade 2 or 3 of at least 4 weeks' duration were included in the study.[12,13] All patients had been diagnosed with type 1 or type 2 diabetes mellitus.[14] Adequate renal function (serum creatinine < 3.0 mg/dL) and a hemoglobin (Hb) A1c level less than 9% were required for inclusion in the study. Every subject underwent computed tomography angiography to confirm patency of the pertinent arterial vessels. Doppler arterial waveforms provided adjunctive evidence, marked by triphasic or biphasic patterns at the ankle level of the extremity with the DFU. Results of serial wound cultures indicated no definite bacterial growth or only controlled flora (ie, few colony-forming units). There were 31 patients with ischemic DFUs and 6 patients with uncontrolled infection excluded. The remaining 49 patients were classified into 2 groups: treatment group (ADM paste, n = 23) and control group (conventional foam dressing, n = 26). The management technique between the 2 methods was selected in accordance with permuted-block randomization (block size 4). A study author (ML) generated the random sequence using Excel (Microsoft Corporation, Redmond, WA). The allocation sequence was utilized to adequately distribute the dressing methods. The patients were blinded until the allocation; nonetheless, further blinding was not available since the dressing method exhibited different materials in procedures. The selection did not depend on patients' demographics and wound sites. The inclusion and exclusion criteria for study eligibility are summarized in Table 1.

First, the DFUs were prepared using careful debridement and vigorous irrigation, before the ADM paste was applied (CG paste; CG Bio, Seongnam-si, Gyeonggi-do, South Korea) in the treatment group only (Figure 1). The amount of ADM paste needed depended on ulcer size and depth. Light surface compaction was used to avoid dead space, and a nonadhesive foam dressing was applied to the surface for containment (Figure 2). In the control group, treatment solely consisted of ulcer bed preparation, overlaying the ulcer with the same type of foam dressing. Dressings were changed every 3 to 4 days. To redistribute pressure on the plantar surface of the foot, the authors used a removable cast walker specifically designed to eliminate pressure on the DFU.

Figure 1.

Introduction of acellular dermal matrix (ADM) paste. (A) The ADM paste under microscope (x30 magnification) using transmission electron microscope; (B) measurement of micronized collagen particles; and (C) 1mL of ADM paste in prefilled syringe.

Figure 2.

Acellular dermal matrix (ADM) paste application. (A) Wagner grade 2 ulcer of left great toe; (B) conservative debridement, ready for ADM paste; (C) ADM paste introduced at deepest portion of ulcer; and (D) surface lightly compacted to avoid dead space.

The area and depth of the ulcers were measured at baseline (before initiating wound management) and at each dressing change. A single study author (DJ), blinded to the treatment protocol, conducted all measurements. The measurements were performed twice at each visit, and the mean was used for data analysis. The maximum length, width, and depth of each wound were determined using a sterilized ruler. Following Tamir et al,[7] ulcer area was calculated as length multiplied by width multiplied by 1/4 π. Full tissue ingrowth and reepithelialization without discharge constituted complete healing. Ulcer evaluations also were recorded on days 20, 40, and 60 after ADM paste application.

The t test for unpaired samples was used to compare continuous variables between the treatment and control groups. Pearson's chi-square test was used to compare categorical variables, including the rates of wound healing. Probabilities of healing were generated via Kaplan-Meier method. All data analyses were performed with standard software (SPSS Windows v20.0; IBM Corp, Armonk, NY). The statistical significance was set at P < .05, expressing all data as mean ± standard deviation.

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