UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001068 |
|---|---|
| Receipt number | R000001297 |
| Scientific Title | Effects of gelatin sheet incorporating basic fibroblast growth factor for treatments of skin ulcers |
| Date of disclosure of the study information | 2009/03/31 |
| Last modified on | 2016/11/29 13:30:18 |
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Basic information
Public title
Effects of gelatin sheet incorporating basic fibroblast growth factor for treatments of skin ulcers
Acronym
Effects of gelatin sheet incorporating basic fibroblast growth factor for treatments of skin ulcers
Scientific Title
Effects of gelatin sheet incorporating basic fibroblast growth factor for treatments of skin ulcers
Scientific Title:Acronym
Effects of gelatin sheet incorporating basic fibroblast growth factor for treatments of skin ulcers
Region
| Japan |
Condition
Condition
Skin ulcers
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe and evaluate the treatment of skin ulcers using gelatin sheet incorporating basic fibroblast growth factor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wound closure by spontaneous healing or skin graft
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Application of gelatin sheet incorporated basic fibroblast growth factor
Interventions/Control_2
Standard wound care
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Skin ulcers, burn ulcers and pressure sores without infection
Key exclusion criteria
Patients were excluded if they had active infection, or malignant disease within 5 years. Written informed consent was obtained from all patients.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Mizuno |
Organization
Nippon Medical School
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nippon Medical School
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
TEL
03-5814-6208
Homepage URL
hmizuno@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
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
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
日本医科大学（勤務地変更のため、現在一時中断中。新勤務地で再開予定）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 03 | Month | 31 | 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
| 2008 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 03 | Month | 06 | Day |
Last modified on
| 2016 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001297
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
