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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name