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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028657
Receipt No. 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

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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
Email 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
Email ohzawa-s@cc.okayama-u.ac.jp

Sponsor
Institute Department of cardiovascular surgery, Okayama University hospital
Institute
Department

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
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
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
URL(English) https://upload.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


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