UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000831 |
|---|---|
| Receipt number | R000000998 |
| Scientific Title | Trial in diabetic ulcer Using basic Fibroblast Growth Factor(KCB-1) |
| Date of disclosure of the study information | 2007/09/21 |
| Last modified on | 2009/09/04 16:19:23 |
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Basic information
Public title
Trial in diabetic ulcer Using basic Fibroblast Growth Factor(KCB-1)
Acronym
Trial in diabetic ulcer Using basic Fibroblast Growth Factor(KCB-1)
Scientific Title
Trial in diabetic ulcer Using basic Fibroblast Growth Factor(KCB-1)
Scientific Title:Acronym
Trial in diabetic ulcer Using basic Fibroblast Growth Factor(KCB-1)
Region
| Japan |
Condition
Condition
Diabetic ulcer
Classification by specialty
| Endocrinology and Metabolism | Dermatology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical efficacy of KCB-1 for diabetic ulcer and the dose-response relationship.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Ulcer shrinkage evaluate: Grade 1 achievement {Marked reduction in the ulcer area (at least 75%) or depth (at least 75%) } during 8-week follow-up
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
KCB-1 0.01% administration group: 30micro gram of trafermin. once a day for 8 weeks.
Interventions/Control_2
KCB-1 0.001% administration group: 3 micro gram of trafermin. once a day for 8 weeks.
Interventions/Control_3
Placebo administration group: 0 micro gram of trafermin. once a day for 8 weeks.
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) ulcer measuring 900 mm2 or less(Attending physicians selected a target ulcer in the presence of multiple ulcers.)
(2) age: =>20
(3) sex: male and female,
setting: hospitalized and outpatient
(4) patients providing written informed consent
Key exclusion criteria
(1) patients who have a target ulcer with a serious infection
(2) patients who have a target ulcer reaching the periosteum
(3) patients whose pulsation of the dorsal artery of foot or posterior tibial artery can not be palpable.
However, patients are enrolled in this study if the ankle-brachial index at rest is not less than 0.9 in patients with no palpable pulsation of either artery (excluding those with severe calcification due to maintenance hemodialysis or diabetes).
(4) patients with bedsores
(5) patients with a malignant tumor or a history of a malignant tumor
(6) patients with a history of hypersensitivity reactions to KCB-1
(7) patients with other serious comorbid disease
(8) patients receiving oral administration or injection of adrenocortical steroids at 20 mg/day or greater doses as prednisolone
(9) patients who participated in a clinical study within 6 months prior to this study
(10) women with confirmed or suspected pregnancy, nursing women, women who would like to become pregnant during the trial
(11) patients having been judged to be ineligible to participate in this study by the attending physicians for any other reason
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masutaka Furue |
Organization
Kyushu University Hospital
Division name
Department of Dermatology
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
KAKEN PHARMACEUTICAL CO., LTD.
Division name
Clinical Development Department
Zip code
Address
2-28-8, Honkomagome, Bunkyo-ku, Tokyo, 113-8650, Japan
TEL
Homepage URL
Sponsor or person
Institute
KAKEN PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAKEN PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit 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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 09 | Month | 21 | 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
| 2004 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2006 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2006 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 09 | Month | 21 | Day |
Last modified on
| 2009 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000998
