Diabetes mellitus (DM)is the fastest developing metabolic disease in the world, and diabetes peripheral vascular disease (DPVD) is a common chronic complication. The presence of the DPVD, in addition to increasing the risk of lameness, ischemic ulcer, gangrene and possible amputation, is also a marker of systemic atherosclerosis and a strong predictor of cardiovascular ischemic events, which brings great pain to patients and increases the economic burden. Traditional Chinese medicine (TCM) is often used to treat DPVD with oral and external treatment, which has a certain effect. The number of clinical trials related to Traditional Chinese medicine prevention and treatment of diabetes peripheral vascular disease (TCM-DPVD) is increasing every year, but the results of clinical trial studies are highly heterogeneous. The heterogeneity of experimental results hinders the synthesis of clinical outcomes in meta-analysis and reduces the value of clinical trials. There is a risk of bias in selective reporting in clinical studies, which hinders the acquisition of evidence for TCM prevention and treatment of DPVD. The establishment of a core set of clinical trial indicators can effectively change this situation. This study searched the database before applying for registration of the core indicator set (COS) of TCM-DPVD, and found that there were two COS registration information of peripheral vascular diseases (https://www.comet-initiative.org/Studies/Details/2650, https://www.comet-initiative.org/Studies/Details/1590), but neither of these two studies mentioned and paid attention to peripheral vascular diseases caused by diabetes, and did not stipulate that the intervention method was traditional Chinese medicine. We have also retrieved some research on the COS of clinical trials on diabetes foot ulcer (https://www.comet-initiative.org/Studies/Details/1138, https://www.comet-initiative.org/Studies/Details/2515), but we believe that diabetes foot is one of the progressive complications of peripheral vascular disease of diabetes. Therefore, we believe that it is necessary and urgent to establish the clinical trial COS of TCM-DPVD to assess the symptom change and prognosis of peripheral vascular disease caused by diabetes after the intervention of traditional Chinese medicine.
ContributorsPrincipal investigator:
Junhua Zhang, Mingyan Zhang, Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China
Other contributors: Zexi Zhang, Bin Wang, Yuntao Ma, jun Zhang, Qianjin Yang, Department of Endocrinology and Metabolism, The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China
Disease Category: Endocrine & metabolic
Disease Name: Diabetes peripheral vascular disease
Age Range: 0 - 100
Sex: Either
Nature of Intervention: Complementary and alternative medicine (CAM) therapy, Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Consumers (patients)
- Researchers
- COS for practice
- Consensus conference
- Delphi process
- Interview
- Systematic review
(1) Systematic literature review
(2) Qualitative semi-structured interview
(3) Two rounds Delphi Survey
(4) Consensus conference