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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035333
Receipt No. R000040254
Scientific Title Clinical study of the effect of disposable warmer on Vasodilatation/Angiogenesis for the patients with Upper limb Circulation disorder
Date of disclosure of the study information 2018/12/21
Last modified on 2018/12/21

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Basic information
Public title Clinical study of the effect of disposable warmer on Vasodilatation/Angiogenesis for the patients with Upper limb Circulation disorder
Acronym VANG-UCir
Scientific Title Clinical study of the effect of disposable warmer on Vasodilatation/Angiogenesis for the patients with Upper limb Circulation disorder
Scientific Title:Acronym VANG-UCir
Region
Japan

Condition
Condition Systemic Sclerosis
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For patients with systemic sclerosis showing Raynaud's phenomenon, it is examined whether warming the cervix, elbow or hand joint with a warmer to see if the effect on the vasodilator and angiogenic factors in the periphery of the fingers appears .
Basic objectives2 Others
Basic objectives -Others To explore the induction by the heat stimulation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum concentration of angiopoietin-1
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Out-patients of Osaka University Hospital
Patients who are participating the Clinical study of Usability and Safety under the use of disposable warmer on each site for the patients with Upper limb Circulation disorder (US-UCir).
Key exclusion criteria 1. Patients who conflict with exclusion criteria of the Clinical study of Usability and Safety under the use of disposable warmer on each site for the patients with Upper limb Circulation disorder (US-UCir).
2. Patients who have difficulty drawing blood from the elbow vein by curing limbs.
3. Patients with skin ulcer at the apex of the finger.
4. Patients judged by the researcher as inappropriate.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihito Shima
Organization Osaka University Graduate School of Medicine
Division name Thermo-therapeutics for Vascular dysfunction
Zip code
Address 1-3 Yamada-oka, Suita city, 565-0871 Osaka, Japan
TEL 06(6105)5710
Email ryanjin@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akane Watanabe
Organization Osaka University Graduate School of Medicine
Division name Thermo-therapeutics for Vascular dysfunction
Zip code
Address 1-3 Yamada-oka, Suita city, 565-0871 Osaka, Japan
TEL 06(6105)5710
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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Serum angiopoietin-1 and eNOS concentrarion are going to measure.

Management information
Registered date
2018 Year 12 Month 21 Day
Last modified on
2018 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040254

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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