UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028657 |
|---|---|
| Receipt number | R000032570 |
| Scientific Title | Safety and functional test for medical denim |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2018/04/15 10:36:04 |
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Basic information
Public title
Safety and functional test for medical denim
Acronym
Safety and functional test for medical denim
Scientific Title
Safety and functional test for medical denim
Scientific Title:Acronym
Safety and functional test for medical denim
Region
| Japan |
Condition
Condition
edema, deep vein thrombosis, varix, lymphoedema
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
test of noninferiority between medical stockings and strech denim
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
check the circumference Diameter at pre and after 3days wearing.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
3days compression therapy for legs
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy
Key exclusion criteria
non healthy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Ozawa |
Organization
Okayama University Hospital
Division name
Cardiovascular surgery
Zip code
Address
2-5-1, Shikata-cyo, Kita, Okayama
TEL
086-235-7359
ohzawa-s@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Ozawa |
Organization
Okayama University Hospital
Division name
Cardiovascular surgery
Zip code
Address
2-5-1, Shikata-cyo, Kita, Okayama
TEL
086-235-7359
Homepage URL
ohzawa-s@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of cardiovascular surgery, Okayama University hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima Prefecture
Organization
Division
Category of Funding Organization
Local Government
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
| 2017 | Year | 10 | Month | 01 | 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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 14 | Day |
Last modified on
| 2018 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032570
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
