UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037364
Receipt number R000042601
Scientific Title Elucidation of the mechanisms of tissue injury in patients with Chronic limb threatening ischemia.
Date of disclosure of the study information 2019/07/13
Last modified on 2024/02/07 14:28:54

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Basic information

Public title

Elucidation of the mechanisms of tissue injury in patients with Chronic limb threatening ischemia.

Acronym

Elucidation of the mechanisms of tissue injury in patients with Chronic limb threatening ischemia.

Scientific Title

Elucidation of the mechanisms of tissue injury in patients with Chronic limb threatening ischemia.

Scientific Title:Acronym

Elucidation of the mechanisms of tissue injury in patients with Chronic limb threatening ischemia.

Region

Japan


Condition

Condition

Chronic limb threatening ischemia

Classification by specialty

Cardiology Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The mechanism of tissue injury in patients with limb threatening ischemia is not well understood.
The present study is aimed to elucidate this process.

Basic objectives2

Others

Basic objectives -Others

elucidating liquid factors affecting ischemic tissue necrosis

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

analysis of proteins affecting tissue necrosis

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

scheduled to be performed amputation because of chronic limb ischemia

Key exclusion criteria

acute limb ischemia

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Daijirou
Middle name
Last name Akamatsu

Organization

Tohoku University

Division name

Department of Surgery

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku Sendai, Japan

TEL

022-717-7214

Email

daijirou@surg.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Daijirou
Middle name
Last name Akamatsu

Organization

Tohoku University

Division name

Department of Surgery

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku Sendai, Japan

TEL

022-717-7214

Homepage URL


Email

daijirou@surg.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohojku University, Department of Surgery

Address

1-1 Seiryo-machi, Aoba-ku Sendai, Japan

Tel

022-717-7214

Email

daijirou@surg.med.tohoku.ac.jp


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

2019 Year 07 Month 13 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

28

Results

under analysis

Results date posted

2020 Year 07 Month 13 Day

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

2019 Year 09 Month 01 Day

Date of IRB

2019 Year 10 Month 01 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2027 Year 10 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study


Management information

Registered date

2019 Year 07 Month 13 Day

Last modified on

2024 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042601


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name