Clinical evaluation of Tangzu granule in the treatment of high-risk foot of diabetes
- Conditions
- High risk foot of diabetes
- Registration Number
- ITMCTR2200006534
- Lead Sponsor
- Hospital of Chengdu University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Meet the diagnostic criteria for type 2 diabetes defined in the Guideline for the prevention and treatment of type diabetes mellitus in China (2020 edition);
2.Meet the diagnostic criteria for high-risk foot for diabetes;
3.Age between 18 and 80 years old, regardless of gender;
4.Voluntarily participate in this trial and sign the informed consent.
1. Patients with typical diabetic foot symptoms such as foot ulcers, infections, and gangrene;
2.There are other diseases that cause damage to peripheral nerves and blood vessels;
3.Mentally ill patients;
4.Combined with serious heart, brain, kidney and other complications, or combined with other serious primary diseases;
5.Those who have a history of allergies or allergies to drugs, food, pollen, etc.;
6.Pregnant, lactating women and women planning to become pregnant;
7.Those who use hormones and undergo surgical treatment and other stressful states of the body;
8.Patients with acute diabetic complications such as ketoacidosis and hyperosmolarity and concurrent infections;
9.Patients who use antioxidant drugs (such as lipoic acid), anti-platelet aggregation drugs (such as aspirin enteric-coated tablets), Chinese patent medicines and other nerve and vascular disease prevention drugs and nutritional nerve preparations (such as methylcobalamin);
10.Those who have participated in other clinical trials within three months.
Note: Patients who meet any of the above should be excluded.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ankle/ branchial index;Toronto clinical scoring system;nerve conduction velocity;local symptom scale;
- Secondary Outcome Measures
Name Time Method lower extremity ultrasound;blood lipids;EQ-5D-5L Quality of Life Evaluation Form;Infrared thermal imaging;VAS;hemorheology;