UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021602 |
|---|---|
| Receipt number | R000024902 |
| Scientific Title | Effects of Electrical Stimulation Therapy on the Blood Flow of Chronic Critical Limb Ischemia |
| Date of disclosure of the study information | 2016/03/25 |
| Last modified on | 2016/03/30 18:28:43 |
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Basic information
Public title
Effects of Electrical Stimulation Therapy on the Blood Flow of Chronic Critical Limb Ischemia
Acronym
Effects of Electrical Stimulation Therapy on the Blood Flow of Chronic Critical Limb Ischemia
Scientific Title
Effects of Electrical Stimulation Therapy on the Blood Flow of Chronic Critical Limb Ischemia
Scientific Title:Acronym
Effects of Electrical Stimulation Therapy on the Blood Flow of Chronic Critical Limb Ischemia
Region
| Japan |
Condition
Condition
Chronic Critical Limb Ischemia Following Regenerative Therapy,healthy young subjects, elderly subjects
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the effects of electrical stimulation (ES) therapy on cutaneous and muscle blood flow in critical limb ischemia (CLI) patients following regenerative therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The HHb and HbO2 concentrations and the Hbtot profiles using a customized continuous wave NIRS device
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ESis applied at 5-Hz frequency at 150-microsec intervals for a 10 min duration.
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
healthy young subjects
elderly subjects
chronic critical limb ischemia patients after regenerative therapy
Written IC
Key exclusion criteria
dementia
severe ulcer
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirokazu Shiraisi |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
Rehabilitation Unit
Zip code
Address
465 Kawaramachi Hirokouji Kmigyoku,kyoto602-8566
TEL
075-251-5552
siraisih@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiho Yamabata |
Organization
University Hospital, Kyoto Prefectural University of Medicine
Division name
Rehabilitation Unit
Zip code
Address
465 Kawaramachi Hirokouji Kmigyoku,kyoto602-8566
TEL
075-251-5552
Homepage URL
shihoy@koto.kpu-m.ac.jp
Sponsor or person
Institute
University Hospital, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 25 | 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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 24 | Day |
Last modified on
| 2016 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024902
