UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004265
Receipt number R000002051
Scientific Title evaluation of safety and efficacy of therapeutic angiogenesis by low-energy extracorporeal shock wave to peripheral arterial disease
Date of disclosure of the study information 2010/09/27
Last modified on 2016/12/12 12:17:56

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Basic information

Public title

evaluation of safety and efficacy of therapeutic angiogenesis by low-energy extracorporeal shock wave to peripheral arterial disease

Acronym

evaluation of safety and efficacy of low-energy extracorporeal shock wave therapy

Scientific Title

evaluation of safety and efficacy of therapeutic angiogenesis by low-energy extracorporeal shock wave to peripheral arterial disease

Scientific Title:Acronym

evaluation of safety and efficacy of low-energy extracorporeal shock wave therapy

Region

Japan


Condition

Condition

peripheral arterial disease

Classification by specialty

Cardiology Vascular surgery Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of extracorporeal shock wave therapy for the patients with peripheral arterial disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

adverse event

Key secondary outcomes

tissue blood flow


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

extracorporeal shock wave

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

the patients with peripheral artery disease more than Fontaine stage 2

Key exclusion criteria

The patients can not agree with this study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuhei Tara

Organization

Nippon Medical School

Division name

Department of Medicine (Division of Cardiology, Hepatology, Geriatrics and Integrated Medicine)

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan

TEL

03-3822-2131

Email

s5062@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Manabu Uwajima

Organization

Nippon Medical School

Division name

General affairs

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan

TEL

03-3822-2131

Homepage URL


Email

youdo@nms.ac.jp


Sponsor or person

Institute

Department of Medicine
(Division of Cardiology, Hepatology,
Geriatrics and Integrated Medicine)

Institute

Department

Personal name



Funding Source

Organization

none

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

日本医科大学付属病院(東京都)


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 27 Day


Related information

URL releasing protocol


Publication of results

Published


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

2009 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 02 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

2010 Year 09 Month 25 Day

Last modified on

2016 Year 12 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002051


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name