Efficacy of Jiedu Tongluo Tiaogan Formula on Type 2 Diabetic Lower Extremity Arteriosclerosis Obliterans: Study Protocol for a Metabolomics-Based Randomized Controlled Clinical Trial

IntroductionDiabetic lower extremity arteriosclerosis obstruction (DLASO) is a common macrovascular complication in type 2 diabetic mellitus (T2DM), which can cause amputations and a higher risk of cardiovascular events. However, there are few effective treatments for DLASO currently. To evaluate the safety and efficacy of Jiedu Tongluo Tiaogan Formula (JTTF) in type 2 diabetic lower extremity arteriosclerosis obliterans and looking for a mechanism of action, we designed a clinical trial and mechanism exploration based on metabolomics technology. Methods and AnalysisThis study is designed as a randomized controlled clinical trial. A total of 80 participants will be recruited and randomized to a TCM group (JTTF + essential treatments) and a control group (essential treatments) in a ratio of 1:1. The treatment duration is 12 weeks. Changes in clinical symptom scores, color ultrasound Doppler hemodynamics of lower extremity arteries, and Ankle-Brachial Ratio (ABI) will be the primary outcomes. Changes in TCM symptoms scores, other indicators related to arteriosclerosis, blood glucose, lipids, and body mass will be the secondary outcomes. The primary and secondary outcomes will be evaluated at baseline and week 12. Safety outcomes and adverse events will also be properly assessed. After treatment completion, blood and urine samples from subjects will be tested for metabolomics. DiscussionThis study aims to verify the efficacy and safety of JTTF in type 2 diabetic lower extremity arteriosclerosis obliterans and obtain the key action pathway. It helps to provide scientific evidence for TCM treatment of diabetic vascular complications. Ethics and DisseminationThis trial has been approved by the Ethics Committee (GZYLL(KY)-2021-024). Results of this trial will be published in journals and presented at scientific conferences. We share raw data in the ResMan network platform. All the authors declare that they have no conflicts of interest. Trial registrationChinese Clinical Trials Register, ChiCTR2100051337. Registered on 20 September 2021.