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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0005088

Enrollment

Registered

2020-06-04

Start date

2021-06-08

Completion date

Unknown

Last updated

2022-11-28

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

Conditions

None listed

Interventions

Drug : This study compares the subjects who administer the Anplone® SR (Sarpogrelate HCl) and aspirin in patients with type 2 diabetic peripheral vascular disease and evaluates the effect on ischemic

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in diastolic 1s-1 whole blood viscosity	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public Contactsoo lim

Seoul National University Bundang Hospital

limsoomd@gmail.com+82-31-787-7035

Outcome results