Effects of Sarpogrelate sustained release treatment on improvement of ischemic symptoms and hepatologic changes(whole blood viscosity changes) in patients with type 2 diabetic peripheral vascular disease, Single-center, randomized, open, Parallel, Phase 4 clinical trial

Not Applicable

Recruiting

Conditions: Endocrine, nutritional and metabolic diseases

Registration Number: KCT0005088

Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Adults aged = 19 years ~ < 80 years
2. Patients with diabetic peripheral vascular disease who are administered Anplone® SR 300 mg (Sarpogrelate HCl) and aspirin
3. Those who are ABI(ankle brachial pressure index test) 0.9 within 1 year
4. Those with type 2 diabetes who have clinical pain (ischemic symptom of chronic arterial occlusion) evaluation result 30 mm or more (100 mm Pain VAS) at visit 2
5. Those who have not changed any other concomitant drugs (antihypertensives, insulin), including oral hypoglycemic agents within 3 months
6. Those with HbA1c (glycosylated hemoglobin) less than 10%
7. Those who voluntarily sign a written consent and agree to participate in the study

Exclusion Criteria

1) Those who have bleeding within one week of participating in the study
2) Those who have a disease (hemophilia, capillary fragility, gastrointestinal ulcer, urinary bleeding, hemoptysis, vitreous hemorrhage, etc.) that may increase bleeding during study participation
3) Patients with cerebrovascular and cardiovascular complications within 6 months (Cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass graft, PCI)
4) Patients with severe renal or hepatic disease
5) Female patients who are or may be pregnant
6) Female patients who are or will be breastfeeding at the time of study participation

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in diastolic 1s-1 whole blood viscosity

Secondary Outcome Measures

Name	Time	Method
Change of whole blood viscosity of 1s-1 ~ 1000s-1;Changes in tissue oxygen delivery index (TODI);Change in red blood cell volume ratio (Hematocrit%);Evaluation of ischemia