UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034907
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

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Basic information

Public title

Study of investigation of the Usability and Skin temperature of fingers under the use of disposable warmers for Healthy volunteer

Acronym

UT-HEAL study

Scientific Title

Study of investigation of the Usability and Skin temperature of fingers under the use of disposable warmers for Healthy volunteer

Scientific Title:Acronym

UT-HEAL study

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual analog scaling of "cold sensation" evaluate by each participants

Key secondary outcomes

Visual analog scale data of interference degree on daily activities by wearing holder of warmers


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

Treatment

Type of intervention

Other

Interventions/Control_1

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.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

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

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yoshihito
Middle name
Last name Shima

Organization

Osaka University Graduate School of Medicine

Division name

Thermo-therapeutics for Vascular dysfunction

Zip code

565-0871

Address

1-3Yamada-oka, Suita, 5650871, Japan

TEL

06-6879-5710

Email

ryanjin@imed3.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Akane
Middle name
Last name Watanabe

Organization

Osaka University Graduate School of Medicine

Division name

Thermo-therapeutics for Vascular dysfunction

Zip code

565-0871

Address

1-3Yamada-oka, Suita, 5650871, Japan

TEL

06-6879-5710

Homepage URL


Email

a.watanabe@imed3.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

Kiribai Chemical Co.,Ltd.
Kobayashi Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JP


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka University Clinical Research Review Committee

Address

2-2Yamada-oka, Suita, 5650871, Japan

Tel

0662108296

Email

handai-nintei@hp-crc.med.osaka-u.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

2018 Year 11 Month 16 Day


Related information

URL releasing protocol

not published

Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/onki/advpub/0/advpub_2330/_article/-char/ja/

Number of participants that the trial has enrolled

30

Results

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.

Results date posted

2019 Year 11 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 07 Month 28 Day

Baseline Characteristics

The normal subjects with acral coldness

Participant flow

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.

Adverse events

Skin itching on the wrists: 2,
Grade 1 burn :2,
Grade 2 burn with a blister: 1,
Hives :2

Outcome measures

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)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 11 Month 16 Day

Date of IRB

2018 Year 11 Month 30 Day

Anticipated trial start date

2018 Year 12 Month 04 Day

Last follow-up date

2019 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 11 Month 16 Day

Last modified on

2020 Year 12 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039461


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name