UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038705 |
|---|---|
| Receipt number | R000044127 |
| Scientific Title | Study on the effect of compression socks made by a new concept |
| Date of disclosure of the study information | 2019/12/15 |
| Last modified on | 2020/05/29 10:00:40 |
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Basic information
Public title
Study on the effect of compression socks made by a new concept
Acronym
Study on the effect of compression socks made by a new concept
Scientific Title
Study on the effect of compression socks made by a new concept
Scientific Title:Acronym
Study on the effect of compression socks made by a new concept
Region
| Japan |
Condition
Condition
Swelling of lower leg
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is to verify the effectiveness of socks made by the new concept for healthy people, using a verification protocol in a medical elastic stocking that shows the effect of improving the swelling of the foot for treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Results from air plethysmography (APG) as follows:
VV: venous volume: The storage volume of the leg veins in the standing position.
VFI: Venous filling index: Venous blood storage rate of the lower limbs in the standing position.
EF: ejection fraction: Active lower limb venous return ability due to lower leg muscle pump action.
Key secondary outcomes
Questionnaires for effectiveness and feeling of wear.
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
We ask subjects to wear socks made by Sukeno Co. that are already widely available on the market as general commercial products.
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Faculty members and staffs wishing to participate in this research.
Key exclusion criteria
Subjects who were found to have venous disease of the lower extremity by ultrasonography.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Akita |
Organization
Tokyo Medical and Dental University
Division name
Department of Clinical Anatomy
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5390
akita.fana@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Akita |
Organization
Tokyo Medical and Dental University
Division name
Department of Clinical Anatomy
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo, Tokyo
TEL
03-5803-5390
Homepage URL
akita.fana@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo, Tokyo
Tel
03-5803-5390
akita.fana@tmd.ac.jp
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
| 2019 | Year | 12 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2019 | Year | 11 | Month | 27 | 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=R000044127
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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