Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. May 15, 2024; 15(5): 923-934
Published online May 15, 2024. doi: 10.4239/wjd.v15.i5.923
Efficacy of Huangma Ding or autologous platelet-rich gel for the diabetic lower extremity arterial disease patients with foot ulcers
Xue-Qin Wang, Dan-Lan Pu, Wei-Ling Leng, Xiao-Tian Lei, Jiang Juan, Zou La, Ding Yao, Jia-Zhuang Xi, Li Jian, Teng Miao, Qi-Nan Wu
Xue-Qin Wang, Teng Miao, Endocrinology Department, The People’s Hospital of Yubei District of Chongqing City, Chongqing 401120, China
Dan-Lan Pu, Department of Endocrinology, Chongqing Yubei District People’s Hospital, Chongqing 400030, China
Wei-Ling Leng, Xiao-Tian Lei, Endocrinology Department, The First Affiliated Hospital of the Army Medical University, Chongqing 400038, China
Jiang Juan, Zou La, Ding Yao, Endocrinology and Nephrology Department, Chongqing University Cancer Hospital and Chongqing Cancer Institute and Chongqing Cancer Hospital, Chongqing 400016, China
Jia-Zhuang Xi, Li Jian, Qi-Nan Wu, Department of Endocrinology, Dazu Hospital of Chongqing Medical University, The People’s Hospital of Dazu, Chongqing 402360, China
Co-first authors: Xue-Qin Wang and Dan-Lan Pu.
Co-corresponding authors: Teng Miao and Qi-Nan Wu.
Author contributions: Wang XQ, Miao T, Pu DL, and Wu QN contributed to writing the manuscript and participated in helpful discussions; Wang XQ, Leng WL, Lei XT, Juan J, La Z, Yao D, Xi JZ, Jian L, and Pu DL participated in the management of the patients and in the data collection and analysis; Wu QN is the guarantor of this work.
Supported by the Chongqing Science and Technology Bureau and Health Commission of Chinese Medicine Technology Innovation and Application Development Project, No. 2020ZY013540; General Project of Chongqing Natural Science Foundation, No. CSTB2023NSCQ-MSX0246 and No. CSTB2022NSCQ-MSX1271; and Science and Health Joint Project of Dazu District Science and Technology Bureau, No. DZKJ2022JSYJ1001.
Institutional review board statement: The study protocol was approved by the Dazu Hospital of Chongqing Medical University and The People’s Hospital of Dazu (Approval No. 2023-71).
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Clinical trial registration statement: This study is registered at ClinicalTrials.gov. The registration identification number is NCT 03248466.
Conflict-of-interest statement: The authors have no conflicts of interest.
Data sharing statement: All the data and materials that are required to reproduce these findings can be shared by contacting the corresponding author Qi-Nan Wu, wqn11@126.com.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Qi-Nan Wu, MD, Chief Physician, Department of Endocrinology, Dazu Hospital of Chongqing Medical University, The People’s Hospital of Dazu, No. 1073 Second Ring South Road, Hongxing Community, Tangxiang Street, Dazu District, Chongqing 402360, China. wqn11@126.com
Received: November 5, 2023
Peer-review started: November 5, 2023
First decision: January 25, 2024
Revised: February 1, 2024
Accepted: March 19, 2024
Article in press: March 19, 2024
Published online: May 15, 2024
Processing time: 187 Days and 6.6 Hours
ARTICLE HIGHLIGHTS
Research background

Diabetes foot is one of the most serious complications of diabetes and an important cause of death and disability. Traditional treatment has poor efficacy and there is an urgent need to develop practical treatment methods.

Research motivation

Our previous study found that the addition of Huangma ding can significantly improve the healing rate of diabetes foot ulcers, but the mechanism is unclear. To investigate the role and mechanism of Huangma ding in promoting wound healing of diabetes foot ulcers, we conducted this study.

Research objectives

To investigate whether Huangma Ding or autologous platelet-rich gel (APG) treatment would benefit diabetic lower extremity arterial disease (LEAD) patients with foot ulcers.

Research methods

Diabetic LEAD patients with foot ulcers were enrolled and divided into three groups. All patients underwent routine follow-up visits for six months. We calculated the changes in all variables from baseline and determined the differences.

Research results

Our research indicated that diabetic foot ulcers (DFUs) lead to major amputation, minor amputation, and total amputation through local infection and poor microcirculation and macrocirculation.

Research conclusions

Huangma Ding and APG were effective at treating DFUs. The clinical efficacy of Huangma Ding was better than that of autologous platelet gel, which may be related to the better control of local infection by Huangma Ding. In DFUs caused by coinfection, controlling infection is as important as improving circulation.

Research perspectives

The clinical efficacy of Huangma Ding was better than that of autologous platelet gel, which may be related to the better control of local infection by Huangma Ding.