UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009313 |
|---|---|
| Receipt number | 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 11:48:52 |
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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
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
Sponsor or person
Institute
Cardiovascular Division, Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010931
