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糖尿病足溃疡(DFU)是糖尿病的严重并发症之一,致残率高、截肢率高,严重影响患者的身心健康.中医外用药治疗DFU具有一定的疗效和优势.本文分析了DFU的临床特点和外用药应用现状,提出了研发治疗DFU的中医外用新药的必要性,指出了DFU中药新药研发过程中的难点和临床试验研究时的关注点,并给出了初步的建议.“,”Diabetic foot ulcer (DFU) is one of the serious complications of diabetes.With high disability,high amputation rate,serious harm to the physical and mental health of diabetes patients.Traditional Chinese medicine drugs for external use has a certain effect and advantages for treatment of DFU.In this paper analyzes the clinical characteristics of DFU and the status of external drug application,and the necessity of research and development of traditional Chinese medicine for DFU treatment.In the article pointed out the difficulties and of the concerns in process of clinical trials for the DFU traditional Chinese medicine research and development.The preliminary recommendations are given in this article.