UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002671 |
|---|---|
| Receipt number | R000003251 |
| Scientific Title | A study of therapeutic angiogenesis in critical limb ischemia using gelatin hydrogel incorporating basic fibroblast growth factor |
| Date of disclosure of the study information | 2009/10/26 |
| Last modified on | 2013/05/30 14:38:14 |
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Basic information
Public title
A study of therapeutic angiogenesis in critical limb ischemia using gelatin hydrogel incorporating basic fibroblast growth factor
Acronym
Therapeutic angiogenesis by basic fibroblast growth factor
Scientific Title
A study of therapeutic angiogenesis in critical limb ischemia using gelatin hydrogel incorporating basic fibroblast growth factor
Scientific Title:Acronym
Therapeutic angiogenesis by basic fibroblast growth factor
Region
| Japan |
Condition
Condition
Arteriosclerosis obliterans
Buerger's disease
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and feasibility of the sustained release system of bFGF from gelatin hydrogel in patients with critical limb ischemia, which had no option of medical or surgical treatment
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transcutanous oxygen tension (TcO2)
Adverse events
Side effects
Key secondary outcomes
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
Muscular injection of gelatin hydrogel incorporating basic fibroblast growth factor
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with arteriosclerosis obliterans or Burger's disease, which had no option for medical or surgical treatment
Key exclusion criteria
Hemodialysis
Active diabetic retinopathy
Active malignancy
Current smoker
Allergy for gelatin
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuzo Sakata |
Organization
Kyoto University Graduate School of Medicine
Division name
Cardiovascular Surgery
Zip code
Address
54 Shogoin-Kawahara, Sakyo, Kyoto
TEL
075-751-3780
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Graduate School of Medicine
Division name
Cardiovascular Surgery
Zip code
Address
TEL
075-751-3784
Homepage URL
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Department of Cardiovascular Surgery
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学医学部附属病院
Kyoto University Hospital
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 26 | 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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 26 | Day |
Last modified on
| 2013 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003251
