UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035042
Receipt No. R000039718
Scientific Title Open study of TKKT01 for Diabetic Ulcers
Date of disclosure of the study information 2018/11/28
Last modified on 2019/05/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kawaim@rohto.co.jp

Sponsor
Institute ROHTO pharmaceutical CO.,LTD
Institute
Department

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
Email

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 Open public recruiting
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
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039718

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.