UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037364 |
|---|---|
| Receipt number | R000042601 |
| Scientific Title | Elucidation of the mechanisms of tissue injury in patients with Chronic limb threatening ischemia. |
| Date of disclosure of the study information | 2019/07/13 |
| Last modified on | 2024/02/07 14:28:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Elucidation of the mechanisms of tissue injury in patients with Chronic limb threatening ischemia.
Acronym
Elucidation of the mechanisms of tissue injury in patients with Chronic limb threatening ischemia.
Scientific Title
Elucidation of the mechanisms of tissue injury in patients with Chronic limb threatening ischemia.
Scientific Title:Acronym
Elucidation of the mechanisms of tissue injury in patients with Chronic limb threatening ischemia.
Region
| Japan |
Condition
Condition
Chronic limb threatening ischemia
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The mechanism of tissue injury in patients with limb threatening ischemia is not well understood.
The present study is aimed to elucidate this process.
Basic objectives2
Others
Basic objectives -Others
elucidating liquid factors affecting ischemic tissue necrosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
analysis of proteins affecting tissue necrosis
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
scheduled to be performed amputation because of chronic limb ischemia
Key exclusion criteria
acute limb ischemia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daijirou |
| Middle name | |
| Last name | Akamatsu |
Organization
Tohoku University
Division name
Department of Surgery
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku Sendai, Japan
TEL
022-717-7214
daijirou@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Daijirou |
| Middle name | |
| Last name | Akamatsu |
Organization
Tohoku University
Division name
Department of Surgery
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku Sendai, Japan
TEL
022-717-7214
Homepage URL
daijirou@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohojku University, Department of Surgery
Address
1-1 Seiryo-machi, Aoba-ku Sendai, Japan
Tel
022-717-7214
daijirou@surg.med.tohoku.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
| 2019 | Year | 07 | Month | 13 | 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
28
Results
under analysis
Results date posted
| 2020 | Year | 07 | Month | 13 | Day |
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
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2019 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042601
