UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003404 |
|---|---|
| Receipt number | R000003341 |
| Scientific Title | Trials in chronic skin ulcers using new collagen substitutes incorporating basic fibroblast growth factor |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2014/05/30 13:30:52 |
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Basic information
Public title
Trials in chronic skin ulcers using new collagen substitutes incorporating basic fibroblast growth factor
Acronym
Trials in chronic skin ulcers using new collagen substitutes incorporating basic fibroblast growth factor
Scientific Title
Trials in chronic skin ulcers using new collagen substitutes incorporating basic fibroblast growth factor
Scientific Title:Acronym
Trials in chronic skin ulcers using new collagen substitutes incorporating basic fibroblast growth factor
Region
| Japan |
Condition
Condition
chronic skin ulcers
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy and safety of new new collagen substitutes incorporating basic fibroblast growth factor for chronic skin ulcers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Improvement of wound 2 weeks after implantation
Key secondary outcomes
1.adverse event
2.wound area
3.granulation area
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Application of artificial dermis
(7microgram/ cm2 of trafermin)
Interventions/Control_2
Application of artificial dermis
(14microgram/ cm2 of trafermin)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient's ulcer has been present for a minimum of 1 month
2. Maximum area of ulcer is within 70mmx100mm
3.Skin Perfusion Pressure at the proximal margin or distal
margin of patient's ulcer(existing in lower extremity) is more than 30mmHg.
4.age: =>20
5. patients providing written informed consent
Key exclusion criteria
1.Decubitus with pocket
2.Patient's ulcer is with extensive exposure of tendon or bone
3.Ulcer with a infection
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigehiko Suzuki |
Organization
Kyoto University Hospital
Division name
department of Plastic and Reconstructive surgery
Zip code
Address
54, Sho-goinkawahara-tyo,Sakyo-Ku,Kyoto-city
TEL
075-751-4460
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Morimoto |
Organization
Kyoto University Hospital
Division name
department of Plastic and Reconstructive surgery
Zip code
Address
54, Sho-goinkawahara-tyo,Sakyo-Ku,Kyoto-city
TEL
075-751-4460
Homepage URL
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 29 | Day |
Last modified on
| 2014 | 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=R000003341
