UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039631 |
|---|---|
| Receipt number | R000045201 |
| Scientific Title | A confirmatory, self-controlled study of peripheral skin temperature-decreasing effect of elastic compression gloves and stockings in healthy volunteers |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2020/03/07 06:25:26 |
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Basic information
Public title
A confirmatory, self-controlled study of peripheral skin temperature-decreasing effect of elastic compression gloves and stockings in healthy volunteers
Acronym
A confirmatory, self-controlled study of peripheral skin temperature-decreasing effect of elastic compression gloves and stockings in healthy volunteers
Scientific Title
A confirmatory, self-controlled study of peripheral skin temperature-decreasing effect of elastic compression gloves and stockings in healthy volunteers
Scientific Title:Acronym
A confirmatory, self-controlled study of peripheral skin temperature-decreasing effect of elastic compression gloves and stockings in healthy volunteers
Region
| Japan |
Condition
Condition
Normal healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm peripheral skin temperature-decreasing effect of elastic compression gloves and stockings (ECGS) in healthy volunteers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Peripheral skin temperature (hands and foot) 2 hours after compression using ECGS
Key secondary outcomes
Compression measurement
Blood pressure in the lower legs
SpO2
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
Compression with ECGS on the hand and leg of the intervention side, and wearing the glove and stocking without compression on the control side for 2 hours
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1,Japanese healthy adult men and women aged from 30 to 60 years old at the time of the screening
2,A person who is judged eligible for the study subject by the investigator or sub-investigator based on a result of the screening
3,Applicants who have been fully informed about the purpose and contents of this medical device and this study (including restrictions on subjects and others), and have given written consent to participate in the study on their own initiative
Key exclusion criteria
1,A person who has a current disease
2,A person having medical history (such as diseases of the heart, liver, kidney, lung, blood) that is considered inappropriate for this study
3,A person who is currently participating in other clinical studies
4,A person who received a drug product in the participation in a Phase I clinical study within 16 weeks before this study, or in the participation in a clinical study within 12 weeks before this study
5,A person who is considered inappropriate by the investigators (examples: in case there are signs of peripheral circulatory insufficiency such as Raynaud phenomenon, or there is a rash requiring treatment, etc.)
6,A person who does not have the appropriate size in the prepared gloves and stockings, or that whose stocking size is SS.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Nobuko |
| Middle name | |
| Last name | KAWAGUCHI |
Organization
Kyoto University Hospital
Division name
Clinical oncology
Zip code
606-8397
Address
54 Shogoin Kawara-cho Sakyo-ku, Kyoto
TEL
075-751-3111
nobuko75@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | TAKANO |
Organization
Medical Corporation Hokubukai UTSUKUSHIGAOKA Hospital Clinical Pharmacology Center
Division name
Pharmacology Center, interlocking head
Zip code
004-0839
Address
61-1 Kiyota-ku, Shin-ei, Sapporo-shi, Hokkaido
TEL
011-882-0111
Homepage URL
info@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai
Utsukushigaoka Hospital Clinical Pharmacology Center
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Utsukushigaoka Hospital IRB
Address
61-1 Kiyota-ku, Shin-ei, Sapporo-shi, Hokkaido
Tel
011-882-0111
info@ughp-cpc.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
医療法人北武会美しが丘病院臨床薬理センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | 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
| 2020 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045201
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
