UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001518 |
|---|---|
| Receipt number | R000001832 |
| Scientific Title | Trials in diabetic foot ulcer using autologous fobroblast-seeded collagen substitutes |
| Date of disclosure of the study information | 2008/12/01 |
| Last modified on | 2012/10/29 13:24:07 |
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Basic information
Public title
Trials in diabetic foot ulcer using autologous fobroblast-seeded collagen substitutes
Acronym
Trials in diabetic foot ulcer using autologous fobroblast-seeded collagen substitutes
Scientific Title
Trials in diabetic foot ulcer using autologous fobroblast-seeded collagen substitutes
Scientific Title:Acronym
Trials in diabetic foot ulcer using autologous fobroblast-seeded collagen substitutes
Region
| Japan |
Condition
Condition
diabetic foot ulcer
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy and safety of autologous fobroblast-seeded substitutes for diabetic foot ulcer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of wound bed 3 weeks after implantation
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
| Device,equipment |
Interventions/Control_1
implantation of autologous fibroblast-seded substitute
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient's ulcer is on the leg or foot
Patient's ulcer has been present for a minimum of 1 month
SPP (Skin Perfusion Pressure) at the proximal margin or distal
margin of patient's ulcer is more than 25mmHg.
Key exclusion criteria
Patient's ulcer is with extensive exposure of tendon or bone
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigehiko Suzuki |
Organization
Kyoto-university
Division name
department of Plastic and Reconstructive surgery
Zip code
Address
54, Sho-goinkawahara-tyo,Sakyo-Ku,Kyoto-city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Morimoto |
Organization
Kyoto University
Division name
department of Plastic and Reconstructive surgery
Zip code
Address
54, Sho-goinkawahara-tyo,Sakyo-Ku,Kyoto-city
TEL
0757514460
Homepage URL
Sponsor or person
Institute
Kyoto-University
Institute
Department
Personal name
Funding Source
Organization
Kyoto university
Organization
Division
Category of Funding Organization
Self funding
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
| 2008 | Year | 12 | 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
| 2008 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 21 | Day |
Last modified on
| 2012 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001832
