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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035514
Receipt No. R000040463
Official scientific title of the study Clinical study on treatment for pressure ulcer with arginine
Date of disclosure of the study information 2019/01/11
Last modified on 2019/01/11

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Basic information
Official scientific title of the study Clinical study on treatment for pressure ulcer with arginine
Title of the study (Brief title) Treatment for pressure ulcer with arginine
Region
Japan

Condition
Condition pressure ulcer
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare pressure ulcers treated with arginine and without arginine
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes DESINGN-R scoore
Key secondary outcomes Laboratory date

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 arginine
Interventions/Control_2 without arginine
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 DESIGN-R D3 or more
oral nutrition or enteral nutrition
Key exclusion criteria patients with renal dysfunction
parenteral nutrition
Target sample size 20

Research contact person
Name of lead principal investigator Kazumitsu Sugiura
Organization Fujita Health University
Division name Department of Dermatology, School of Medicine
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake city, Aichi prefecture, Japan, 470-1192
TEL 0562-93-9256
Email ksugiura@fujita-hu.ac.jp

Public contact
Name of contact person Tsukane Kobayashi
Organization Fujita Health University
Division name Department of Dermatology, School of Medicine
Address 1-98 Dengakugakubo, Kutsukake-cho, Toyoake city, Aichi prefecture, Japan, 470-1192
TEL 0562-93-9256
Homepage URL
Email kikuchiyo1982@gmail.com

Sponsor
Institute Fujita Health University
Institute
Department

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)

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 01 Month 11 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 03 Month 04 Day
Anticipated trial start date
2016 Year 04 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 01 Month 11 Day
Last modified on
2019 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040463

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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