UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040915 |
|---|---|
| Receipt number | R000046719 |
| Scientific Title | Association between lower extremity ulcers and peritonitis in patients on peritoneal dialysis |
| Date of disclosure of the study information | 2020/06/27 |
| Last modified on | 2023/06/08 14:22:46 |
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Basic information
Public title
Association between lower extremity ulcers and peritonitis in patients on peritoneal dialysis
Acronym
Association between lower extremity ulcers and peritonitis in patients on peritoneal dialysis
Scientific Title
Association between lower extremity ulcers and peritonitis in patients on peritoneal dialysis
Scientific Title:Acronym
Association between lower extremity ulcers and peritonitis in patients on peritoneal dialysis
Region
| Japan |
Condition
Condition
Chronic Renal Failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Anticipation and prevention of peritonitis in the treatment of PD patients is essential to improve the quality of PD care. Therefore, the purpose of this study was to determine the association between leg ulcers and PD-related peritonitis in PD patients attending our hospital.
Basic objectives2
Others
Basic objectives -Others
Correlation between lower extremity ulcers and peritonitis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between lower extremity ulcers and peritonitis
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
PD patients who were introduced to PD and attended PD outpatient clinic at Nippon Medical School Hospital from April 1, 2015 to March 31, 2020.
Key exclusion criteria
1) Does not meet the above selection criteria
2) The physician in charge of the study has deemed the study unsuitable for enrollment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukinao |
| Middle name | |
| Last name | Sakai |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
y-sakai@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yukinao |
| Middle name | |
| Last name | Sakai |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
y-sakai@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Department of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Department of Nephrology
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
Ethical Council of Nippon Medical School Hospital
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
nms_fuzokurinri@nms.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
| 2020 | Year | 06 | Month | 27 | 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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2020 | Year | 06 | Month | 27 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046719
