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Clinical Trials/JPRN-UMIN000005277
JPRN-UMIN000005277
Completed
Phase 1

Clinical trial of new therapeutic angiogenesis for peripheral artery disease - New therapeutic angiogenesis for peripheral artery disease

Kyoto Prefectural University of Medicine0 sites10 target enrollmentMarch 18, 2011

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Arteriosclerosis obliterans Buerger&#39
Sponsor
Kyoto Prefectural University of Medicine
Enrollment
10
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 18, 2011
End Date
March 1, 2013
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • (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.

Outcomes

Primary Outcomes

Not specified

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