UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035042 |
|---|---|
| Receipt number | R000039718 |
| Scientific Title | Open study of TKKT01 for Diabetic Ulcers |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2020/05/29 09:40:43 |
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Basic information
Public title
Open study of TKKT01 for Diabetic Ulcers
Acronym
Open study of TKKT01 for Diabetic Ulcers
Scientific Title
Open study of TKKT01 for Diabetic Ulcers
Scientific Title:Acronym
Open study of TKKT01 for Diabetic Ulcers
Region
| Japan |
Condition
Condition
Diabetic ulcers
Classification by specialty
| Dermatology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of TKKT01 on the intractable diabetic ulcers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of patients who have the =>50% wound radius reduction.
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
A gel prepared by TKKT01 will be administered twice a week and be kept for 8 weeks.
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
1) =>20 years of age on the day of signing the informed consent.
2) Diabetic ulcers that have not healed with standard therapy over 4 weeks.
Key exclusion criteria
1) Patient who has serious immune diseases/liver diseases/heart diseases/blood diseases/endocrine diseases/mental diseases etc.
2) Patient who has the following diseases
- immunodeficiency/various platelet abnormalities/malignant tumor/collagen disease/various blood diseases
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Kawai |
Organization
ROHTO pharmaceutical CO.,LTD
Division name
Clinical development group Development & Planning office
Zip code
Address
6-5-4Kunimidai, Kizugawa, Kyoto, Japan
TEL
0774-71-8820
kawaim@rohto.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Kawai |
Organization
ROHTO pharmaceutical CO.,LTD
Division name
Clinical development group Development & Planning office
Zip code
Address
6-5-4Kunimidai, Kizugawa, Kyoto, Japan
TEL
0774-71-8820
Homepage URL
kawaim@rohto.co.jp
Sponsor or person
Institute
ROHTO pharmaceutical CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
ROHTO pharmaceutical CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 28 | 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
| 2018 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2020 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039718
