Hyung Min Hahn1, Dong Hwan Lee, Il Jae Lee. 1. At the Ajou University School of Medicine, Suwon, Republic of Korea, Hyung Min Hahn, MD, is Assistant Professor; Dong Hwan Lee, MD, is a Resident; Il Jae Lee, MD, PhD, is Associate Professor, Department of Plastic and Reconstructive Surgery. Acknowledgments: The authors thank Editage (www.editage.co.kr) for English language editing. This research was supported by a Korea Health Industry Development Institute grant to Ajou University Medical Center. The authors have disclosed no other financial relationships related to this article. Submitted May 28, 2020; accepted in revised form September 3, 2020.
Abstract
OBJECTIVE: To examine and report clinical outcomes of a ready-to-use micronized dermal matrix for diabetic foot ulcers (DFUs) and compare it to treatment with conventional negative-pressure wound therapy (NPWT) only. METHODS: The researchers randomly allocated 30 DFUs Wagner grade 2 or higher from 30 adult patients into two groups. The control group (n = 15) was treated with conventional NPWT, and the experimental group (n = 15) was treated with micronized dermal matrix and NPWT. The researchers evaluated the following outcomes: granulation tissue formation, proportion of patients with closed or granulated wounds at 42 and 120 days, achievement of complete wound healing in the 6 months of follow-up, and intervals from enrollment to final surgical procedures. RESULTS: All 15 wounds treated with the micronized matrix showed healthy granulation tissue without noticeable complications during follow-up. At 42 days, 46.7% of wounds in the experimental group had closed compared with 28.6% in the conventional NPWT group (P = .007). At 120 days, 86.7% of the experimental group had completely closed wounds, compared with 57.1% in the conventional therapy group (P = .040). During the 6-month follow-up period, 93.3% of the experimental group achieved complete wound healing compared with 85.7% of the conventional therapy group (P = .468). CONCLUSIONS: The healing outcomes for DFUs in the experimental group were superior when micronized matrix treatment was combined with NPWT.
RCT Entities:
OBJECTIVE: To examine and report clinical outcomes of a ready-to-use micronized dermal matrix for diabetic foot ulcers (DFUs) and compare it to treatment with conventional negative-pressure wound therapy (NPWT) only. METHODS: The researchers randomly allocated 30 DFUs Wagner grade 2 or higher from 30 adult patients into two groups. The control group (n = 15) was treated with conventional NPWT, and the experimental group (n = 15) was treated with micronized dermal matrix and NPWT. The researchers evaluated the following outcomes: granulation tissue formation, proportion of patients with closed or granulated wounds at 42 and 120 days, achievement of complete wound healing in the 6 months of follow-up, and intervals from enrollment to final surgical procedures. RESULTS: All 15 wounds treated with the micronized matrix showed healthy granulation tissue without noticeable complications during follow-up. At 42 days, 46.7% of wounds in the experimental group had closed compared with 28.6% in the conventional NPWT group (P = .007). At 120 days, 86.7% of the experimental group had completely closed wounds, compared with 57.1% in the conventional therapy group (P = .040). During the 6-month follow-up period, 93.3% of the experimental group achieved complete wound healing compared with 85.7% of the conventional therapy group (P = .468). CONCLUSIONS: The healing outcomes for DFUs in the experimental group were superior when micronized matrix treatment was combined with NPWT.