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
Abstract
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 a practical treatment method.

AIM

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

METHODS

A total of 155 diabetic LEAD patients with foot ulcers were enrolled and divided into three groups: Group A (62 patients; basal treatment), Group B (38 patients; basal treatment and APG), and Group C (55 patients; basal treatment and Huangma Ding). All patients underwent routine follow-up visits for six months. After follow-up, we calculated the changes in all variables from baseline and determined the differences between groups and the relationships between parameters.

RESULTS

The infection status of the three groups before treatment was the same. Procalcitonin (PCT) improved after APG and Huangma Ding treatment more than after traditional treatment and was significantly greater in Group C than in Group B. Logistic regression analysis revealed that PCT was positively correlated with total amputation, primary amputation, and minor amputation rates. The ankle-brachial pressure and the transcutaneous oxygen pressure in Groups B and C were greater than those in Group A. The major amputation rate, minor amputation rate, and total amputation times in Groups B and C were lower than those in Group A.

CONCLUSION

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. Huangma Ding and APG were effective attreating 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. This finding suggested that in patients with DFUs combined with coinfection, controlling infection is as important as improving circulation.

Keywords: Diabetic foot ulcer, Huangma Ding, Autologous platelet-rich gel, Ankle-brachial index, Transcutaneous oxygen partial pressure

Core Tip: We investigated whether Huangma Ding or autologous platelet-rich gel (APG) treatment would benefit diabetic lower extremity arterial disease patients with foot ulcers. Our research indicated that diabetes foot ulcers lead to major amputation, minor amputation, and total amputation through local infection and poor microcirculation and macrocirculation. Huangma Ding and APG were effective at treating diabetic foot ulcers. 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.