You H J, Han S K, Rhie J W
Clinical Instructor, Department of Plastic Surgery, Korea University College of Medicine, Seoul, Korea.
J Wound Care. 2014 Nov;23(11):521-2, 524, 526-30. doi: 10.12968/jowc.2014.23.11.521.
Diabetic foot ulcers (DFUs) often pose a treatment problem. Bioengineered skin substitutes have been reported to result in accelerated diabetic wound healing. The purpose of this clinical trial was to evaluate the efficacy and safety of the autologous fibroblast-hyaluronic acid complex for treating DFUs.
A stratified, randomised, controlled, multicentre study was carried out. Patients with DFUs were allocated to either a treatment group with grafting of an autologous fibroblast-hyaluronic acid complex or a control group with non-adherent foam dressing. Except for application of the fibroblast complex, treatment of the study ulcers was identical for patients in both groups. The maximum follow-up period for each patient was 12 weeks.
Complete ulcer healing was achieved in 84% (26/31 patients) of the treatment group and 34% (11/32 patients) of the control group (p<0.05). The times required for complete healing were 36.4 ± 17.6 and 48.4 ± 13.1 days in the treatment and control groups, respectively (p<0.05). No adverse events related to treatment occurred.
These results indicate that autologous fibroblast-hyaluronic acid complex may offer a safe and effective treatment for DFUs.
糖尿病足溃疡（DFUs）常常带来治疗难题。据报道，生物工程皮肤替代物可加速糖尿病伤口愈合。本临床试验的目的是评估自体成纤维细胞 - 透明质酸复合物治疗DFUs的疗效和安全性。
开展了一项分层、随机、对照、多中心研究。患有DFUs的患者被分配至接受自体成纤维细胞 - 透明质酸复合物移植的治疗组或接受非粘性泡沫敷料的对照组。除了应用成纤维细胞复合物外，两组患者对研究溃疡的治疗方法相同。每位患者的最长随访期为12周。
治疗组84%（26/31例患者）实现溃疡完全愈合，对照组为34%（11/32例患者）（p<0.05）。治疗组和对照组实现完全愈合所需时间分别为36.4±17.6天和48.4±13.1天（p<0.05）。未发生与治疗相关的不良事件。
这些结果表明，自体成纤维细胞 - 透明质酸复合物可能为DFUs提供一种安全有效的治疗方法。
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