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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016680
Receipt No. R000019354
Scientific Title Far Infrared Theraphy on Peripheral Arterial Disease in Hemodialysis Patients.
Date of disclosure of the study information 2015/03/07
Last modified on 2015/03/02

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Basic information
Public title Far Infrared Theraphy on Peripheral Arterial Disease in Hemodialysis Patients.
Acronym FIT on PAD in HD patients
Scientific Title Far Infrared Theraphy on Peripheral Arterial Disease in Hemodialysis Patients.
Scientific Title:Acronym FIT on PAD in HD patients
Region
Japan

Condition
Condition PAD in Hemodialysis patients
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Safty/Efficasy of FIT on PAD in HD patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes skin perfusion pressure
Key secondary outcomes diminution rate of skin ulcer
ankle-brachial-index
duration of hospitalization

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Far Infrared theraphy
(WS Far Infrared Medical Technology Co.,Ltd., Taipei, Taiwan)
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

Not applicable
Gender Male and Female
Key inclusion criteria continuing more than one year on Hemodialysis
Key exclusion criteria blood clotting defect
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Io
Organization Juntendo University
Division name Nephrology
Zip code
Address 2-1-1 Hongou, Bunkyou-ku, Tokyo, Japan
TEL 03-3813-3111
Email hiroaki@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Io
Organization Juntendo University
Division name Nephrology
Zip code
Address 2-1-1 Hongou, Bunkyou-ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email hiroaki@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Division of Nephrology, Department of
Juntendo University Faculty of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2015 Year 03 Month 07 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 Enrolling by invitation
Date of protocol fixation
2015 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 03 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 02 Day
Last modified on
2015 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019354

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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