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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004901
Receipt No. R000004087
Scientific Title Clinical trial of effects of Low-intensity Pulsed Ultrasound (LIPUS) on angiogenesis and safety in patients with critical limb ischemia
Date of disclosure of the study information 2011/01/19
Last modified on 2011/11/07

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Basic information
Public title Clinical trial of effects of Low-intensity Pulsed Ultrasound (LIPUS) on angiogenesis and safety in patients with critical limb ischemia
Acronym LIPUS study
Scientific Title Clinical trial of effects of Low-intensity Pulsed Ultrasound (LIPUS) on angiogenesis and safety in patients with critical limb ischemia
Scientific Title:Acronym LIPUS study
Region
Japan

Condition
Condition patients with arteriosclerotic peripheral arterial disease, Buerger's disease
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to determine the effects of LIPUS on angiogenesis and safety in patients with limb ischemial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes flow-mediated vasodilation (FMD)
Key secondary outcomes ABPI, PWV
Clinical symptoms and visual analog score
Safty

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 LIPUS treatment
Interventions/Control_2 LIPUS untreated (control)
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
15 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with critical limb ischemia
Key exclusion criteria Patients with cancer
Patients with stroke and/or myocardial infarction within 12 weeks of the prior to study
Patients with heart failure (&#8805;NYHA4)
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihito Higashi
Organization Hiroshima University Hospital
Division name Division of Regenerative Medicine
Zip code
Address 1-2-3kasumi, minamiku, hiroshima
TEL 082-257-5122
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yukihito Higashi
Organization Hiroshima university Hospital
Division name Division of Regenerative Medicine
Zip code
Address 1-2-3kasumi, minamiku, hiroshima
TEL 082-257-5122
Homepage URL http://home.hiroshima-u.ac.jp/angio/
Email yhigashi@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

Funding Source
Organization Self funding
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
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
2011 Year 01 Month 19 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 Open public recruiting
Date of protocol fixation
2010 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 05 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
2011 Year 01 Month 19 Day
Last modified on
2011 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004087

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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