UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035514 |
|---|---|
| Receipt number | R000040463 |
| Scientific Title | 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 10:20:31 |
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Basic information
Public title
Clinical study on treatment for pressure ulcer with arginine
Acronym
Treatment for pressure ulcer with arginine
Scientific Title
Clinical study on treatment for pressure ulcer with arginine
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazumitsu Sugiura |
Organization
Fujita Health University
Division name
Department of Dermatology, School of Medicine
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake city, Aichi prefecture, Japan, 470-1192
TEL
0562-93-9256
ksugiura@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsukane Kobayashi |
Organization
Fujita Health University
Division name
Department of Dermatology, School of Medicine
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake city, Aichi prefecture, Japan, 470-1192
TEL
0562-93-9256
Homepage URL
kikuchiyo1982@gmail.com
Sponsor or person
Institute
Fujita Health University
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
Address
Tel
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 |
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 04 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040463
