UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050494 |
|---|---|
| Receipt number | R000057515 |
| Scientific Title | Examination of the effect of chronic limb-threatening ischemia in spinal cord stimulation |
| Date of disclosure of the study information | 2023/03/06 |
| Last modified on | 2023/09/21 18:49:22 |
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Basic information
Public title
Examination of the effect of chronic limb-threatening ischemia in spinal cord stimulation
Acronym
Examination of the effect of chronic limb-threatening ischemia in spinal cord stimulation
Scientific Title
Examination of the effect of chronic limb-threatening ischemia in spinal cord stimulation
Scientific Title:Acronym
Examination of the effect of chronic limb-threatening ischemia in spinal cord stimulation
Region
| Japan |
Condition
Condition
chronic limb-threatening ischemia
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The chronic limb-threatening ischemia patients suffered from pain due to ischemia and ulcer during the treatment period. The painkillers are gradually increased and strengthened generally. Several painkillers cause some adverse events. The events rarely dropped treatment of CLTI. Therefore, whether the effects of spinal cord stimulation at an early stage control pain and decrease adverse events is examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Confirm the following points before and after spinal cord stimulation
1. Numerical rating score
2. Amount of analgesic
3. Adverse events
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
chronic limb-threatening ischemia over 20 years old
Key exclusion criteria
Inapplicable cases of spinal cord stimulation
Cases with difficulty in communication
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Terabe |
Organization
Kasukabe Chuo General Hospital
Division name
Limb Salvage center
Zip code
344-0063
Address
midori5-9-4, Kasukabe, Saitama
TEL
048-736-1221
k.sk.tera@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Terabe |
Organization
Kasukabe Chuo General Hospital
Division name
Limb Salvage Center
Zip code
344-0063
Address
midori5-9-4, Kasukabe, Saitama
TEL
048-736-1221
Homepage URL
k.sk.tera@gmail.com
Sponsor or person
Institute
Kasukabe Chuo General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Kasukabe Chuo General Hospital
Address
midori5-9-4, Kasukabe, Saitama
Tel
048-736-1221
k.sk.tera@gmail.com
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
| 2023 | Year | 03 | Month | 06 | 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
Suspended
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
progress
Management information
Registered date
| 2023 | Year | 03 | Month | 05 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057515
