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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046145
Receipt No. R000052668
Scientific Title Lower limb skin temperature change after endovascular treatment in peripheral artery disease patients
Date of disclosure of the study information 2021/11/22
Last modified on 2021/11/22

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Basic information
Public title Lower limb skin temperature change after endovascular treatment in peripheral artery disease patients
Acronym Lower limb skin temperature change after endovascular treatment in peripheral artery disease patients
Scientific Title Lower limb skin temperature change after endovascular treatment in peripheral artery disease patients
Scientific Title:Acronym Lower limb skin temperature change after endovascular treatment in peripheral artery disease patients
Region
Japan

Condition
Condition peripheral artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the association between skin temperature and wound healing after endovascular treatment in peripheral artery disease patients.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Wound healing at 3 months and at 6 months.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria peripheral artery disease patients who receive endovascular treatment
Key exclusion criteria none
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yasunori
Middle name
Last name Ueda
Organization NHO Osaka National Hospital
Division name Cardiovascular Division
Zip code 540-0006
Address 2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA 540-0006, JAPAN
TEL 0669421331
Email yellowplaque@gmail.com

Public contact
Name of contact person
1st name Yasunori
Middle name
Last name Ueda
Organization NHO Osaka National Hospital
Division name Cardiovascular Division
Zip code 540-0006
Address 2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA 540-0006, JAPAN
TEL 0669421331
Homepage URL
Email yellowplaque@gmail.com

Sponsor
Institute NHO Osaka National Hospital
Institute
Department

Funding Source
Organization NHO Osaka National Hospital
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 NHO Osaka National Hospital
Address 2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA 540-0006, JAPAN
Tel 0669421331
Email 408-chiken@mail.hosp.go.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
2021 Year 11 Month 22 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 Enrolling by invitation
Date of protocol fixation
2020 Year 11 Month 27 Day
Date of IRB
2020 Year 12 Month 08 Day
Anticipated trial start date
2020 Year 12 Month 09 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To examine the association between skin temperature and wound healing after endovascular treatment in peripheral artery disease patients.

Management information
Registered date
2021 Year 11 Month 22 Day
Last modified on
2021 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052668

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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