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Integrated Traditional Chinese and Western Medicine Cohort Study and Intelligent Risk Early-Warning System Construction of Diabetic Lower Extremity Arterial Disease

Integrated Traditional Chinese and Western Medicine Cohort Study and Intelligent Risk Early-Warning System Construction of Diabetic Lower Extremity Arterial Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600121448
Enrollment
Unknown
Registered
2026-03-31
Start date
2025-11-24
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic lower extremity arterial disease

Interventions

TCM group:none
non-TCM group:none

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Retrospective cohort 1. according to the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2020 Edition)" issued by the Chinese Diabetes Society of the Chinese Medical Association, those who have been clearly diagnosed with type 2 diabetes; 2. age >=18. Under the premise of meeting all the above criteria, the subjects will be included in the study in the following three phases: 1. High-risk population (Stage 1) (1) At least two of the following high-risk factors must be present: a. Hypertension: A clear diagnosis of hypertension has been made in the past; if no clear diagnosis exists, the office blood pressure must be >= 140/90 mmHg; b. Dyslipidemia: Non-high-density lipoprotein cholesterol >= 4.9 mmol/L, or triglycerides >= 1.7 mmol/L, or total cholesterol >= 4.5 mmol/L, or low-density lipoprotein cholesterol >= 2.6 mmol/L; c. Overweight or obesity: BMI >= 24 kg/m², or central obesity (male waist circumference >= 90 cm, female waist circumference >= 85 cm); d. Smoking history: Continuous or cumulative smoking for more than 6 months, and still smoking currently; e. Age >= 40 years; f. Diabetes duration of more than 5 years; g. Hyperuricemia: Male UA >= 420 mmol/L, female UA >= 360 mmol/L, or gout, gouty arthritis; h. Mild elevation of urinary albumin or mild renal dysfunction: UACR (urinary albumin/muscle creatinine ratio) = 140/90 mmHg; b. Dyslipidemia: Non-high-density lipoprotein cholesterol >= 4.9 mmol/L, or triglycerides >= 1.7 mmol/L, or total cholesterol >= 4.5 mmol/L, or low-density lipoprotein ch

Exclusion criteria

Exclusion criteria: retrospective cohort 1. Only one record of hospitalization or outpatient visit; 2. Lower extremity atherosclerosis or stenosis/occlusion not caused by type 2 diabetes; 3. Having cognitive impairment or mental illness; 4. Having a malignant tumor, or a severe psychosomatic disease, or an expected lifespan of no more than 2 years due to a serious illness. prospective cohort 1. Within the past month, there has been acute metabolic disorders of diabetes such as diabetic ketoacidosis or hyperosmolar hyperglycemic state, or severe stress state; 2. Lower extremity atherosclerosis or stenosis/occlusion caused by non-type 2 diabetes; 3. Within the past month, there has been severe liver function impairment (alanine aminotransferase or aspartate aminotransferase higher than 2.5 times the upper limit of normal) and/or renal function impairment (serum creatinine greater than the upper limit of normal or glomerular filtration rate <= 60 ml/min/1.73 m^2); 4. Has cognitive dysfunction or mental illness and cannot cooperate with the examination; 5. Pregnant women, lactating women or women of childbearing age with fertility requirements; 6. Has malignant tumors, or severe psychosomatic diseases, or has an expected lifespan of no more than 2 years due to serious illness; 7. The investigator determines that the compliance is poor, cannot be regularly followed up, or is otherwise not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Clinical indicator information of Western medicine;The information about four diagnostic methods of TCM and the elements of syndrome differentiation;Western medical treatment situation;Usage of Chinese patent medicines / traditional Chinese medicines;outcome event;

Secondary

MeasureTime frame
Demographic data;General clinical data;personal history;family history;

Countries

China

Contacts

Public ContactXie Chunguang

Hospital of Chengdu University of Traditional Chinese Medicine

xiecg@cdutcm.edu.cn+86 189 8088 0132

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026