Clinical trial of new therapeutic angiogenesis for peripheral artery disease
- Conditions
- Arteriosclerosis obliterans Buerger's disease
- Registration Number
- JPRN-UMIN000005277
- Lead Sponsor
- Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 10
Not provided
(1)Patients with life expectancy likely to be within one year due to complications. (2)Patients are scheduled for major lower limb amputation (3)Patients with angina, congestive heart failure, or ventricular arrhythmia requiring treatment. (4)Patients with myocardial infarction within three months. (5)Left ventricular ejection fraction below 25% (6)Patients with lower extremity revascularization within 3 months. (7)Patient who performed percutaneous coronary intervention, bypass surgery within 1 month. (8)Hemoglobin 7 g /dL or less (9)Platelet count 70,000 / uL or less (10)AST 100 IU or more, or ALT 100 IU or more (11)Patients with malignant neoplasm requiring treatment. (12)Patients with suspected infection and fever. (13)Patients with uncontrolled diabetes over HbA1c 10%. (14)Patients with diabetic proliferating retinopathy requiring treatment. (15)Alprostadil Alfadex (for injection), Alprostadil (injection solution), Argatroban (injection solution), Trafermin (recombinant) in patients who are difficult to stop the worsening of symptoms could be stopped before surgery preparation. (16)Patients with a history of severe drug allergy. (17)Patients with negative skin reaction to decision not test solution. (18)The females who are in pregnancy or lactation, may be pregnant, or are planning. (19)Patients with a history of alcohol or drug dependence in past year. (20)Patients who are considered unsuitable by other principal investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation for Incidence, Severity, and Seriousness of adverse event
- Secondary Outcome Measures
Name Time Method Improvement of Fontaine and Rutherford Classification