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人类羊水膜提取物用于糖尿病足的治疗:一项随机比较研究

Mohammad Azimi Alamouti^1,2, Niloufar Shayan³, Maryam Momeni³

¹Department of Tissue Engineering, School of Advanced Technologies in Medicine, Royan Institute, Tehran, Iran.

Journal of wound care

|January 13, 2026

概括

人类羊水膜提取物 (AME) 有效地治愈糖尿病足 (DFU). 在临床试验中,在标准护理下,局部DiAMX在临床试验中实现了100%的伤口关闭,显示出一种安全有效的治疗选择.

科学领域:

再生医学是一种再生医学.
伤口愈合治愈伤口愈合
皮肤病学皮肤病学

背景情况:

人类羊水膜提取物 (AME) 显示出对上皮细胞修复的前景.
在治疗糖尿病足 (DFU) 中AME的疗效仍在研究中.
在伤口护理中,DFU 构成了重大挑战.

研究的目的:

评估 AME (DiAMX) 在患有难以治愈的 DFU 的患者的安全性和有效性.
为了比较AME加标准护理 (SoC) 与单独SoC的伤口愈合率.
评估AME治疗的患者友好性,成本效益和安全性.

主要方法:

一个随机对照试验,涉及难以治愈的DFU患者.
治疗组接受了局部AME (DiAMX) 与SoC;对照组仅接受了SoC.
每周监测伤口愈合,减少面积和不良事件.

主要成果:

安全阶段证实没有与AME相关的不良事件.
在第6周,AME组的伤口愈合率为100%,对照组的伤口愈合率为77.5% (p<0.0001).
在AME组的所有伤口都关闭了,而在对照组 (p<0.0001) 中只有7个伤口.

结论:

作为SoC的辅助,局部DiAMX对于治愈难治愈的DFU是安全有效的.
该AME治疗是患者友好的,廉价的,并加快了伤口的关闭.
AME代表了DFU管理的有前途的治疗选择.

关键词:

胚胎膜提取物胚胎膜提取物糖尿病足糖尿病足护理的标准护理的标准伤口的伤口是伤口.伤口护理伤口护理伤口上使用了伤口带.伤口愈合伤口愈合

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Diabetic Foot Ulcer

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Definition A diabetic foot ulcer (DFU) is a chronic, non-healing wound that develops in individuals with diabetes. It typically occurs on pressure-bearing areas such as the heel, metatarsal heads, or hallux, and carries a high risk of infection and amputation.Pathophysiology • The development of DFUs can be explained by four interconnected mechanisms: neuropathy, ischemia, infection, and impaired wound healing. • Neuropathy is the most common factor. Sensory neuropathy reduces pain perception,...