UMIN-CTR Clinical Trial

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
Email	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
Email	info@ughp-cpc.jp

Sponsor
Institute	Medical Corporation Hokubukai Utsukushigaoka Hospital Clinical Pharmacology Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045201