Department of Plastic Surgery, Korea University College of Medicine, Seoul, Korea.
Wound Repair Regen. 2012 Jul-Aug;20(4):491-9. doi: 10.1111/j.1524-475X.2012.00809.x. Epub 2012 Jun 1.
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.
糖尿病足溃疡常常是一个治疗难题。有报道称，反复应用基于细胞的产品可加速糖尿病创面愈合。本临床试验研究的目的是报告培养的同种异体角质形成细胞片治疗糖尿病足溃疡的疗效和安全性的初步发现。59 例糖尿病足溃疡患者被随机分为角质形成细胞治疗组（n = 27）或凡士林纱布对照组（n = 32）。除了应用角质形成细胞外，两组患者的研究性溃疡治疗相同。在研究开始时和之后的每周，分别应用角质形成细胞片或凡士林纱布，最多应用 11 周。每位患者的最长随访期为 12 周。治疗组的完全溃疡愈合率为 100%，对照组为 69%（p < 0.05）。角质形成细胞组和对照组完全愈合的 Kaplan-Meier 中位数时间分别为 35 天和 57 天。未发生与治疗相关的不良事件。这些结果表明，培养的同种异体角质形成细胞可能为糖尿病足溃疡提供一种安全有效的治疗方法。
