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

Results

For all 49 patients (treatment group: n = 23; control group: n = 26), the following demographic variables were recorded: age; gender; body mass index (BMI); serum Hb, HbA1c, and albumin levels; and ulcer location. The treatment and control groups were comparable for all variables (Table 2).

Clinical ulcer measurements and outcomes included area and depth of DFUs, follow-up period, and time to complete healing. Ulcer severity (ie, Wagner classification) appeared comparable in both groups (Table 3). In the treatment group, initial ulcer measurements (area: 13.81 cm2 ± 19.30 cm2; depth: 1.03 cm ± 1.23 cm) declined significantly over the course of study (final values; area: 6.87 cm2 ± 10.52 cm2; depth: 0.07 cm ± 0.13 cm; P < .05) (Figures 3, 4). In the control group, initial ulcer dimensions were comparatively less extensive (area: 7.97 cm2 ± 10.00 cm2; depth: 0.93 cm ± 0.63 cm), but also declined significantly (final values; area: 5.90 cm2 ± 8.31 cm2; depth: 0.57 cm ± 0.67 cm; P < .05) (Table 3). However, the rates of ulcer resolution in the treatment (area: 74.17% ± 30.84%; depth: 87.18% ± 18.9%) and control (area: 51.87% ± 32.81%; depth: 45.98% ± 32.89%) groups differed significantly (P < .05) (Table 4). At the end of the follow-up period, 13 of 23 ADM paste-treated patients (56.52%) showed complete healing, whereas only 6 of 26 control patients (23.08%) achieved complete healing (P < .05) (Table 5). The corresponding mean follow-up intervals until complete healing were 33.74 ± 24.51 days and 51.12 ± 17.39 days, representing a significant difference (P < .05). The mean time to complete healing in the treatment group (13.54 ± 9.18 days) was significantly shorter than that of the control group (21.5 ± 11.98 days, P < .05) (Table 3). Further, the mean number of ADM paste applications was 5.74 ± 3.17 in the treatment group overall, and the mean number of applications was 3.68 ± 1.25 in completely healed ulcers.

Figure 3.

Representative patient in treatment group. (A) Initial state, covered with ADM paste; (B) 3 days after first treatment; (C) condition after 4 treatments (day 12); and (D) completely healed ulcer (day 18).

Figure 4.

Representative patient in treatment group. (A) Initial view demonstrating exposed necrotic bone; (B) marginal narrowing of ulcer (day 6); (C) granulation tissue ingrowth (day 18) promoted by serial application of ADM paste; and (D) significant reepithelialization achieved (day 24).

The authors monitored ulcer healing for 60 days to assess healing probability (via Kaplan-Meier estimates). In the per-protocol population, ADM paste application demonstrated significantly greater ulcer healing probability than conventional care within the 60-day period (Figure 5).

Figure 5.

Kaplan-Meier plot of healing probability through day 60 endpoint for per-protocol population.
a Statistically significant difference (acellular dermal matrix [ADM] paste vs. conventional care).

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