UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004901 |
|---|---|
| Receipt number | 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 | 2019/11/12 14:58:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 (≥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
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/
yhigashi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2011 | Year | 01 | Month | 19 | Day |
Last modified on
| 2019 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004087
