Lower extremity artery disease
Conditions
Interventions
Group 1:Prostaglandin therapy
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes patients, gender is not limited. The diagnostic criteria for type 2 diabetes are in accordance with the 2010 edition of the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China. Greater than or equal to 60 years old and less than 80 years old. Less than 60 years old but greater than 50 years old (including) combined with any risk factors for PAD, such as smoking, hypertension, abnormal lipid metabolism, or diabetes for more than 10 years (inclusive); 2. ABI measurement is less than 0.9 or greater than 1.3 (TBI less than 0.7); 3. Glycated hemoglobin is less than 8%; blood pressure is less than 150/90mmHg; 4. There is no typical intermittent claudication PAD symptoms (with identification points); 5. Clinical diagnosis of DPN (symptoms and signs positive) or TSS abnormalities or abnormal DPN-CHECK examination; 6. Ambulatory and consistent with long-term follow-up conditions; 7. ability to have a normal response questionnaire; 8. Subjects voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1. The medical history has one of the following: Type 1 diabetes, pancreatic injury diabetes or secondary diabetes (eg Cushing's syndrome, acromegaly); heart failure, exercise restriction.Treatment of PAD drugs for the past 6 months, such as cilostazol, pentoxifylline, sarpogrelate, warfarin.Severe liver and kidney dysfunction (ALT and AST 3 times normal, CKD 4 and 5 and malignant tumors). History of immunodeficiency disease, including human immunodeficiency virus antibody positive; Any of the following conditions occurred in the past 6 months: acute complications of diabetes (such as diabetic ketoacidosis, hyperosmolar hyperglycemia, or severe hypoglycemia with loss of consciousness), myocardial infarction (if visit 1 ECG) Shows myocardial infarction and cannot determine the date of myocardial infarction, whether the investigator and sponsor decide whether the patient is participating in the study), coronary artery bypass surgery, unstable angina or stroke; Percutaneous coronary intervention for the past 3 months; Participate in any other clinical trials in the past 3 months; Known to be allergic to the drugs used in the study or similar research drugs; 2. Admission to the hospital has one of the following: Pharmacotherapy still cannot control dyslipidemia; Any of the following ECG anomalies: Second degree atrioventricular block (Mohs type I and type II); Third degree atrioventricular block; Long QT interval syndrome, or QTc > 450 milliseconds (male), QTc > 470 milliseconds (female). One of the following laboratory tests during the visit: ALT, AST exceeds 3 times the upper limit of the normal range; Total bilirubin exceeds 1.5 times the upper limit of the normal range.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six minutes walking test;Questionnaires;Neuropathy evaluation;Urinary protein;Any event related to podiatry; | — |
Countries
China
Contacts
Public ContactGeheng Yuan
Peking University First Hospital
Outcome results
None listed