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SYSTEMATIC REVIEW article

Front. Endocrinol.

Sec. Clinical Diabetes

This article is part of the Research TopicInnovative Therapeutic Strategies for Managing Diabetic Foot Ulcers and Mitigating Associated ComplicationsView all 19 articles

Methodological Panorama of Clinical Trials for Diabetic Foot Ulcers: A Scope Review of Design, Implementation and Reporting

Provisionally accepted
Shuo ZhangShuo Zhang1Yanying WangYanying Wang1Ling WangLing Wang2Xuechun FanXuechun Fan1Jinyue ZhaoJinyue Zhao2Yanyan WangYanyan Wang2Jing YuJing Yu2Yongjiang YuYongjiang Yu2Yingjing ShiYingjing Shi3Guanchi YanGuanchi Yan2Jia MiJia Mi4*
  • 1Changchun University of Chinese Medicine, Changchun, China
  • 2Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China
  • 3Changchun Disabled Persons Rehabilitation Center, chang chun, China
  • 4The Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun, China

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Abstract Background Diabetic foot ulcer (DFU) reduce the quality of life for diabetes patients and creates a significant economic burden on global healthcare systems. Although there has been recent progress in DFU clinical trials, most existing scoping reviews have primarily focused on nursing or diagnostic methods. This review analyzed the characteristics of current DFU clinical trials and assessed research methods. This review focused on refining trial design and provide evidence-based methods for improving treatment outcomes and prognosis. Method The study searched clinical trials registered in ClinicalTrials and Chinese Clinical Trial Registry (ChiCTR) (up to August 1, 2025). In addition, the study searched PubMed for clinical trials that were published from August 1, 2015, to August 1, 2025. Data was extracted and presented in tables. Result The study revealed a rapid increase in the number of clinical trials focusing on DFU in recent years. Meanwhile, interventions have grown more varied, with skin transplantation, tissue replacement products, and dressings being widely used in clinical practice. Nonetheless, these studies face challenges, such as low methodological quality, lack of primary care studies, and low follow-up rates. Conclusion The number of DFU clinical trials has increased, and the intervention strategies have become more varied. However, there is a large variation in the populations, design of the studies, and evaluation of their effectiveness.

Keywords: Diabetic foot ulcer, Clinical Trial, Study status, Clinical design, Scope review

Received: 22 Sep 2025; Accepted: 04 Nov 2025.

Copyright: © 2025 Zhang, Wang, Wang, Fan, Zhao, Wang, Yu, Yu, Shi, Yan and Mi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Jia Mi, mijia0101@126.com

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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