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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041809
Receipt No. R000047733
Scientific Title Prospective study on the prognosis of peripheral arterial disease
Date of disclosure of the study information 2020/09/16
Last modified on 2020/09/16

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Basic information
Public title Prospective study on the prognosis of peripheral arterial disease
Acronym Prospective study on the prognosis of peripheral arterial disease
Scientific Title Prospective study on the prognosis of peripheral arterial disease
Scientific Title:Acronym Prospective study on the prognosis of peripheral arterial disease
Region
Japan

Condition
Condition peripheral arterial disease
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Predicting the prognosis of peripheral arterial disease with the general conditions and lower limb conditions
Basic objectives2 Others
Basic objectives -Others Non-interventional observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Scoring with the general conditions and lower limb conditions
Key secondary outcomes Scoring with the general conditions

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent surgery for peripheral arterial disease in our department
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Sano
Organization Hamamatsu University School of Medicine
Division name Departmento of Vascular Surgery
Zip code 4313192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL 053-435-2279
Email m.sano@hama-med.ac.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Sano
Organization Hamamatsu University School of Medicine
Division name Departmento of Vascular Surgery
Zip code 4313192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL 053-435-2279
Homepage URL
Email m.sano@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
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 Hamamatsu University School of Medicine
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
Tel 053-435-2279
Email m.sano@hama-med.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
2020 Year 09 Month 16 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
2020 Year 01 Month 17 Day
Date of IRB
2020 Year 01 Month 17 Day
Anticipated trial start date
2020 Year 01 Month 17 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients were divided into two groups according to the scoring systems with preoperative general conditions and lower limb conditions. Observe the prognosis up to 2 years after surgery.

Management information
Registered date
2020 Year 09 Month 16 Day
Last modified on
2020 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047733

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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