UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016098 |
|---|---|
| Receipt number | R000018696 |
| Scientific Title | The relationship between the patency rate of infrapopliteal lesions after endovascular treatment and wound healing rate in critical limb ischemia with tissue loss |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2021/01/06 09:34:48 |
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Basic information
Public title
The relationship between the patency rate of infrapopliteal lesions after endovascular treatment and wound healing rate in critical limb ischemia with tissue loss
Acronym
the patency rate of infrapopliteal lesions after endovascular treatment and wound healing rate in critical limb ischemia
Scientific Title
The relationship between the patency rate of infrapopliteal lesions after endovascular treatment and wound healing rate in critical limb ischemia with tissue loss
Scientific Title:Acronym
the patency rate of infrapopliteal lesions after endovascular treatment and wound healing rate in critical limb ischemia
Region
| Japan |
Condition
Condition
critical limb ischemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the patency of infrapopliteal lesions assessed by echography after endovascular treatment and wound healing in critical limb ischemia with tissue loss
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patency rate of infrapopliteal lesions and wound healing rate at 1, 2, 3, 6, and 12 months after endovascular treatment
Key secondary outcomes
major amputation free rate, major amputation free survival rate
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Critical limb ischemia patients with tissue loss who are aged 18 years or older
Key exclusion criteria
Patients who may not complete 1 year follow-up
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Kobayashi |
Organization
Saiseikai Yokohama-city Eastern Hospital
Division name
Cardiology
Zip code
230-8765
Address
3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-576-3000
ovation17@gmail.com
Public contact
Name of contact person
| 1st name | Norihiro |
| Middle name | |
| Last name | Kobayashi |
Organization
Saiseikai Yokohama-city Eastern Hospital
Division name
Cardiology
Zip code
230-8765
Address
3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-576-3000
Homepage URL
ovation17@gmail.com
Sponsor or person
Institute
Saiseikai Yokohama-city Eastern Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Saiseikai Yokohama-city Eastern Hospital
Address
3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
Tel
045-576-3000
045-576-3000
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
| 2015 | Year | 01 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the relationship between the patency of infrapopliteal lesions assessed by echography after endovascular treatment and wound healing rate in critical limb ischemia with tissue loss
Management information
Registered date
| 2015 | Year | 01 | Month | 02 | Day |
Last modified on
| 2021 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018696
