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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-C000000200 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for critical limb ischemia
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Scientific title:
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Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for critical limb ischemia - Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for critical limb ischemia |
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Date of first enrolment:
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2004/12/01 |
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Target sample size:
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10 |
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Recruitment status: |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000274 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Tetsuro Miyata |
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Address:
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7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3815-8411 |
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Email:
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Affiliation:
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The University of Tokyo Hospital Department of Surgery, Division of Vascular Surgery |
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Name:
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Hiroyuki Koyama |
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Address:
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7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3815-8411 |
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Email:
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hkoyama-tky@umin.ac.jp |
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Affiliation:
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The University of Tokyo Hospital Department of Vascular Regeneration |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Hypersensitivity for gelatin hydrogel 2. Serious medical co-morbidities 3. Alcoholism or other drug dependence within 3 months 4. Malignancy within 5 years 5. Possibility of malignancy 6. Operations within 3 months 7. Severe diabetic retinopathy 8. Pregnant woman, lactating woman 9. Vascular reconstruction within 2 months 10. Other complication unsuitable for the study
Age minimum:
35years-old
Age maximum:
85years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Arteriosclerosis obliterance Buerger's disease
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Intervention(s)
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Intra-arterial injection of acidic gelatin hydrogel microsphres (3mg)incorporating human recombinant fibroblast growth factor-2 (trafermin, 0.1mg)
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Primary Outcome(s)
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Physical findings Symptoms Ankle pressure index Transcutaneous oximetry Skin perfusion pressure Air plethysmography Angiography
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Secondary Outcome(s)
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Adverse events Serum FGF2 concentration
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Source(s) of Monetary Support
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The Ministry of Education, Science, Sports and Culture
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/09/2008 |
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URL:
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