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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009313
Receipt No. R000010931
Scientific Title Vascular Flow Reserve Immediately After Infrapopliteal Intervention as a Predictor of Wound Healing in Patients with Critical Limb Ischemia
Date of disclosure of the study information 2012/11/13
Last modified on 2015/04/27

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Basic information
Public title Vascular Flow Reserve Immediately After Infrapopliteal Intervention as a Predictor of Wound Healing in Patients with Critical Limb Ischemia
Acronym Vascular Flow Reserve Immediately After Infrapopliteal Intervention as a Predictor of Wound Healing in Patients with Critical Limb Ischemia
Scientific Title Vascular Flow Reserve Immediately After Infrapopliteal Intervention as a Predictor of Wound Healing in Patients with Critical Limb Ischemia
Scientific Title:Acronym Vascular Flow Reserve Immediately After Infrapopliteal Intervention as a Predictor of Wound Healing in Patients with Critical Limb Ischemia
Region
Japan

Condition
Condition Critical Limb Ischemia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The Clinical Impact of Post Procedural Peripheral Vascular Flow Reserve on Wound Healing Following Infrapopliteal Intervention in Patients with Critical Limb Ischemia by using a pressure/temprature sensor tipped tipped guidewire
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The correlation between Vascular Flow Reserve (VFR) and woundhealing
Key secondary outcomes

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 Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 To evaluate the vascular flow reserve after endovascular treatment by using a pressure/temperature sensor-tipped-guidewire
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 with critical limb ischemia underwent endovascular therapy for below-the-knee artery
Key exclusion criteria Patients with rutherford 6 criteria
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohru Masuyama
Organization Hyogo College of Medicine
Division name Cardiovascular Division
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL 0798456553
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Fukunaga
Organization Hyogo College of Medicine
Division name Cardiovascular Division
Zip code
Address
TEL 0798456553
Homepage URL
Email

Sponsor
Institute Cardiovascular Division, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine Division of Cardiology
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 兵庫医科大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially 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
2012 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 13 Day
Last follow-up date
2013 Year 10 Month 31 Day
Date of closure to data entry
2013 Year 10 Month 31 Day
Date trial data considered complete
2013 Year 10 Month 31 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 11 Month 11 Day
Last modified on
2015 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010931

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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