Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu 643001, India.
Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu 643001, India.
Biomed Pharmacother. 2021 Oct;142:111946. doi: 10.1016/j.biopha.2021.111946. Epub 2021 Jul 30.
The treatment of diabetic wounds (DWs) is always challenging for the medical community because of its multifaceted pathophysiology. Due to practical and ethical considerations, direct studies of therapeutic interventions on human subjects are limited. Thus, it is ideal for performing studies on animals having less genetic and biological variability. An ideal DW model should progress toward reproducibility, quantifiable interpretation, therapeutic significance, and effective translation into clinical use. In the last couple of decades, various animal models were developed to examine the complex cellular and biochemical process of skin restoration in DW healing. Also, these models were used to assess the potency of developed active pharmaceutical ingredients and formulations. However, many animal models lack studying mechanisms that can appropriately restate human DW, stay a huge translational challenge. This review discusses the available animal models with their significance in DW experiments and their limitations, focusing on levels of proof of effectiveness in selecting appropriate models to restate the human DW to improve clinical outcomes. Although numerous newer entities and combinatory formulations are very well appreciated preclinically for DW management, they fail in clinical trials, which may be due to improper selection of the appropriate model. The major future challenge could be developing a model that resembles the human DW environment, can potentiate translational research in DW care.
治疗糖尿病创面（DWs）一直是医学领域的挑战，因为其病理生理学具有多方面的特点。由于实际和伦理方面的考虑，对人类受试者进行治疗干预的直接研究受到限制。因此，在遗传和生物学变异性较小的动物身上进行研究是理想的。理想的 DW 模型应该具有可重复性、可量化的解释、治疗意义和有效的临床应用转化。在过去的几十年中，已经开发了各种动物模型来研究 DW 愈合过程中皮肤恢复的复杂细胞和生化过程。此外，这些模型还用于评估开发的活性药物成分和制剂的功效。然而，许多动物模型缺乏能够恰当地再现人类 DW 的研究机制，这仍然是一个巨大的转化挑战。本文综述了现有的动物模型及其在 DW 实验中的意义和局限性，重点讨论了选择合适模型以再现人类 DW 以改善临床结果的有效性水平的证明。尽管许多更新的实体和组合配方在 DW 管理方面具有很好的临床前效果，但在临床试验中却失败了，这可能是由于没有选择合适的模型。未来的主要挑战可能是开发出一种类似于人类 DW 环境的模型，能够促进 DW 护理的转化研究。
