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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035332
Receipt No. R000040206
Scientific Title Clinical study of Usability and Safety under the use of disposable warmer on each site for the patients with Upper limb Circulation disorder
Date of disclosure of the study information 2018/12/21
Last modified on 2019/05/01

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Basic information
Public title Clinical study of Usability and Safety under the use of disposable warmer on each site for the patients with Upper limb Circulation disorder
Acronym US-UCir study
Scientific Title Clinical study of Usability and Safety under the use of disposable warmer on each site for the patients with Upper limb Circulation disorder
Scientific Title:Acronym US-UCir study
Region
Japan

Condition
Condition systemic sclerosis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to explore the safety, the influence to daily living, the subjective symptoms, and the influence to the hand temperture and peripheral blood flow when the patients with systemic sclerosis who present Ranaud's phenomenon use disposable hand warmers on their neck, elbows, or wrists.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analog scale data of subjective evaluation against Raynaud's phenomenon
Key secondary outcomes

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
Device,equipment
Interventions/Control_1 Systemic sclerosis patients with impaired hand blood circulation wear a disposable warmer on the neck, elbow and wrist for 1 week, 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. Patients who are visiting to Osaka University Medical School hospital.
2. Over 20 years old and under 80 years.
3. Systemic scleroderma patients who satisfy the scleroderma diagnostic criteria (1980) of American Society of Rheumatology.
4. Patients who can agree in sentence to the document and verbal explanation.
5. Patients satisfying the above criteria and judged appropriate by the researcher.
Key exclusion criteria 1.Patients complicated with chronic diseases and infectious diseases accompanied by fever.
2.Patients with diabetes mellitus.
3.Patients with skin disorder other than scleroderma in the worn area of the body.
4.Patients who can not detach / attach the device by herself.
5.Patients with peripheral neuropathy or patients who have been diagnosed with peripheral neuropathy (eg, cervical spondylosis, carpal tunnel syndrome).
6.Patients who are judged inappropriate by the researcher.
Target sample size 20

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 1-3 Yamada-oka, Suita city, Osaka565-0871, Japan
TEL 06-6105-5710
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 1-3 Yamada-oka, Suita city, Osaka565-0871, Japan
TEL 0661055710
Homepage URL
Email a.watanabe@imed3.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Joint research project of Osaka University with Kiribai Chemical Co.,Ltd. and 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 2-2Yamadaoka, Suita, Osaka, 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 12 Month 21 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 No longer recruiting
Date of protocol fixation
2018 Year 12 Month 12 Day
Date of IRB
2018 Year 12 Month 21 Day
Anticipated trial start date
2019 Year 01 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 12 Month 21 Day
Last modified on
2019 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040206

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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