Diabetic foot ulcers often pose a difficult treatment problem. Repeated applications of cell-based products have been reported to result in acceleration of diabetic wound healing. The purpose of this clinical trial study was to report preliminary findings of the efficacy and safety of the cultured allogeneic keratinocyte sheets in the treatment of diabetic foot ulcers. Fifty-nine patients with diabetic foot ulcers were randomized to either the keratinocyte treatment group (n = 27) or the control group treated with vaseline gauze (n = 32). Except for the application of keratinocytes, treatment of study ulcers was identical for patients in both groups. Either keratinocyte sheet or vaseline gauze was applied at the beginning of the study and weekly thereafter for a maximum of 11 weeks. The maximum follow-up period for each patient was 12 weeks. Complete ulcer healing was achieved in 100% of the treatment group and 69% of the control group (p < 0.05). The Kaplan-Meier median times to complete closure were 35 and 57 days for the keratinocyte and control groups, respectively. No adverse events related to the treatment occurred. These results indicate that cultured allogeneic keratinocytes may offer a safe and effective treatment for diabetic foot ulcers.
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