Unique ID issued by UMIN | UMIN000034907 |
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Receipt number | R000039461 |
Scientific Title | Study of investigation of the Usability and Skin temperature of fingers under the use of disposable warmers for Healthy volunteer |
Date of disclosure of the study information | 2018/11/16 |
Last modified on | 2020/12/23 19:49:59 |
Study of investigation of the Usability and Skin temperature of fingers under the use of disposable warmers for Healthy volunteer
UT-HEAL study
Study of investigation of the Usability and Skin temperature of fingers under the use of disposable warmers for Healthy volunteer
UT-HEAL study
Japan |
Healthy volunteer
Adult |
Others
NO
It is expected that cold sensation will relief by warming using a disposable warmer, but it has been unknown which part is suitable for warming. Therefore, we warm several sites on healthy volunteers and examine where comfortable and safety.
Safety,Efficacy
Exploratory
Visual analog scaling of "cold sensation" evaluate by each participants
Visual analog scale data of interference degree on daily activities by wearing holder of warmers
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Other |
Eighteen subjects wear a disposable warmer holder with disposable warmer and warm the neck, elbow, and wrist joints for one week in a predetermined order, respectively. Twelve subjects wear the holders only on the neck, elbow, and wrist joints for one week in the predetermined order,respectively.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1. Healthy adults, equal or over 20yo and under 80.
2. A person who is conscious of cold end of extremities
3. The content of the explanatory document of this clinical research can be understood by the subject himself based on the explanation of the research director or research sharing person, and the written subject can be agreed in writing by the subject himself, Person who can observe and evaluate prescribed in the implementation plan and can report subjective symptoms etc.
1. A person who has some kind of skin disorder in the worn area of the body
2. A persons who have underlying diseases such as cardiovascular diseases, kidney diseases, liver diseases, blood diseases, autoimmune diseases and developmental disorders by interview, those whose pathology is not controlled by drug treatment or the like
3. A person who has diabetes
4. A persons with peripheral neuropathy or those who have previously undergone diagnosis of peripheral neuropathy (eg peripheral neuropathy due to cervical spondylosis, carpal tunnel syndrome, etc.)
5. A persons who have difficulty detaching the warmer holders with their own will
6. Other persons who have judged that the research director and research worker are inappropriate as subjects of this clinical study
30
1st name | Yoshihito |
Middle name | |
Last name | Shima |
Osaka University Graduate School of Medicine
Thermo-therapeutics for Vascular dysfunction
565-0871
1-3Yamada-oka, Suita, 5650871, Japan
06-6879-5710
ryanjin@imed3.med.osaka-u.ac.jp
1st name | Akane |
Middle name | |
Last name | Watanabe |
Osaka University Graduate School of Medicine
Thermo-therapeutics for Vascular dysfunction
565-0871
1-3Yamada-oka, Suita, 5650871, Japan
06-6879-5710
a.watanabe@imed3.med.osaka-u.ac.jp
Osaka University
Kiribai Chemical Co.,Ltd.
Kobayashi Pharmaceutical Co.,Ltd.
Profit organization
JP
Osaka University Clinical Research Review Committee
2-2Yamada-oka, Suita, 5650871, Japan
0662108296
handai-nintei@hp-crc.med.osaka-u.ac.jp
NO
2018 | Year | 11 | Month | 16 | Day |
not published
Published
https://www.jstage.jst.go.jp/article/onki/advpub/0/advpub_2330/_article/-char/ja/
30
After obtaining informed consent, 30 people who usually had acral coldness used the warmer holders on the necks, elbows, and wrists.
The VAS of acral coldness of upper limbs decreased during the periods of warming on the neck and elbows with Kairo compared to the period without Kairo. There was no difference in the VAS value of the cumbersomeness among the neck, elbows, and wrists areas. The hand temperature on the day after the end of warming decreased slightly after elbow warming.
2019 | Year | 11 | Month | 18 | Day |
2020 | Year | 07 | Month | 28 | Day |
The normal subjects with acral coldness
The subject was determined whether or not to use the disposable warmer using a lottery, and similarly, the order of wearing the warmer holder was determined.
Skin itching on the wrists: 2,
Grade 1 burn :2,
Grade 2 burn with a blister: 1,
Hives :2
10 cm visual analog scale (VAS) for acral coldness,
10cm VAS for the cumbersomeness,
finger skin temperature evaluated by a thermography,
finger skin blood flow by Laser speckle contrast analysis (LASCA)
Completed
2018 | Year | 11 | Month | 16 | Day |
2018 | Year | 11 | Month | 30 | Day |
2018 | Year | 12 | Month | 04 | Day |
2019 | Year | 04 | Month | 30 | Day |
2018 | Year | 11 | Month | 16 | Day |
2020 | Year | 12 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039461
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