UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005277 |
|---|---|
| Receipt number | R000006272 |
| Scientific Title | Clinical trial of new therapeutic angiogenesis for peripheral artery disease |
| Date of disclosure of the study information | 2011/03/18 |
| Last modified on | 2021/09/26 19:45:58 |
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Basic information
Public title
Clinical trial of new therapeutic angiogenesis for peripheral artery disease
Acronym
New therapeutic angiogenesis for peripheral artery disease
Scientific Title
Clinical trial of new therapeutic angiogenesis for peripheral artery disease
Scientific Title:Acronym
New therapeutic angiogenesis for peripheral artery disease
Region
| Japan |
Condition
Condition
Arteriosclerosis obliterans
Buerger's disease
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of Growth Factor (FGF) containing solution for the patients with PAD (ASO, Buerger's disease), who are unresponsive to standard therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Evaluation for Incidence, Severity, and Seriousness of adverse event
Key secondary outcomes
Improvement of Fontaine and Rutherford Classification
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intramuscular injection of Growth Factor (FGF) containing solution
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with ASO or Buerger's disease
(2) Patient whose Fontaine classification is 3-4 and Rutherford classification is 4-6 in either limb.
(3) Patients with clinical improvement can not be obtained even after any existing medical and surgical treatment.
(4) Patient who can receive the protocol treatment for either limb.
(5) Patients who can give informed consent themselves in writing.
Key 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.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Matsubara |
Organization
Department of Cardiovascular Medicine
Division name
Kyoto Prefectural University of Medicine
Zip code
602-8566
Address
465 Kajii-chyo,Kamigyo-ku, Kyoto
TEL
075-251-5511
matsubah@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Satoaki |
| Middle name | |
| Last name | Matoba |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
TEL
+8100752515511
Homepage URL
matoba@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kamigyo-ku, Kyoto
Tel
0752515511
matoba@koto.kpu-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2009 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 18 | Day |
Last modified on
| 2021 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006272
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| Registered date | File name |
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