Effect of micronized acellular dermal matrix on wound healing and granulation tissue formation in delayed wounds of diabetic foot ulcer patients.

Acellular dermal matrix has been successfully used to heal diabetic foot ulcers. While conventional sheet-type dermal matrix promises wound healing, we report on our study to examine the clinical outcomes of a ready-to-use micronized dermal matrix for diabetic foot ulcers, comparing that with conventional negative pressure wound therapy. This was a prospective, randomized, pilot study of comparing micronized human acellular dermal matrix as an adjunctive treatment for diabetic foot ulcers that required operative debridement with conventional negative pressure wound therapy only. We randomly allocated 30 diabetic foot wounds of Wagner grade 2 or higher in 30 adult patients into 1 of 2 groups. The control group (n=15) was treated with conventional negative pressure wound therapy, and the experimental group (n=15) was treated with micronized dermal matrix and negative pressure wound dressing. We evaluated outcomes included granulation tissue formation, proportion of patients with closed or covered wound at 42 days and at 120 days, achieving complete wound healing during six months of follow-up, and intervals from enrollment to final surgical procedures. One patient in the conventional therapy group withdrew two days after enrollment due to major amputation. All 15 wounds treated with micronized matrix showed healthy granulation tissue without noticeable complications during follow-up. At 42 days, 46.7% of the experimental group had closed compared with 28.6% in the conventional therapy group (p = 0.007). At 120 days, 86.7% of the experimental group had closed completely compared with 57.1% in the conventional therapy group (p = 0.040). During the six-month follow-up period, 93.3% of the experimental group achieved complete wound healing compared with 85.7% of the conventional therapy group (p = 0.468). The healing outcomes in the experimental group were accelerated when combined with the use of negative pressure therapy.