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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002072
Receipt No. R000002526
Scientific Title Effect of nutritional intervention to prevention and treatment of pressure ulcer
Date of disclosure of the study information 2009/06/13
Last modified on 2009/12/17

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Basic information
Public title Effect of nutritional intervention to prevention and treatment of pressure ulcer
Acronym Effect of nutritional intervention to prevention and treatment of pressure ulcer
Scientific Title Effect of nutritional intervention to prevention and treatment of pressure ulcer
Scientific Title:Acronym Effect of nutritional intervention to prevention and treatment of pressure ulcer
Region
Japan

Condition
Condition Pressure ulcer
Classification by specialty
Geriatrics Dermatology Plastic surgery
Rehabilitation medicine Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of nutritional intervention to nutritional condition, risk factors and healing of pressure ulcer in patients who have pressure ulcer or its risk factors of developing pressure ulcer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Nutritional condition(i.anthropometric index, ii. clinical laboratory test results)
Risks of developing pressure ulcer (OH scale, Bladen scale)
Key secondary outcomes Time courses of change in serum iron, cupper and zinc
Time courses of change in morbid bony preminence on sacrum
Time courses of change in edema

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Nutritional intervention group
Interventions/Control_2 Control group
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 Alb: 2.5 to 3.5g/dL
OH scale: less than 8.5
Bladen scale: 9 to 17
Inpatients with more than 12 weeks of objective energy intake by tube feeding
Patients without dehydration
Pressure ulcer cases:
Region of pressure ulcer must be sacrum, coccyx, greater trochanter, and heal. Stage must be 3 or 4(NPUAP)
Area of necrosis tissues must be less than 20% of area of pressure ulcer
The depth of pocket of pressure ulcer must be less than 2 cm
Key exclusion criteria Patients with ileus or no residual intestinal function
Patients with not using
gastrointestinal tract more than 30 days
Patients with laboratory value of AST or ALT is over 2.5 times of criteria in each hospitals
HbA1c:more than 8.0%
Cre:more than 2.0mg/dL
Urinary protein on qualitative analysis:more than 2+
Patients with ASO
Patients with a history of
hypersensitivity or allergy to dressing, ointment, and enteral formula
Patients with cancer or a history of cancer within 5 years
Pressure ulcer cases:
Patients with more than 2 stage 2 to 4(NPUAP) pressure ulcer or wound infection
Patients who determine inappropriate to enroll clinical study by
investigator
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehiko Ohura M.D.,Ph.D
Organization Pressure Ulcer & Wound Healing Reseach Center(Kojin-kai)
Division name Director
Zip code
Address 3F,H&B Plaza Bld.West2,South3,Chuo-ku,Sapporo 060-0063 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Pressure Ulcer & Wound Healing Reseach Center(Kojin-kai)
Division name Secretary
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Pressure Ulcer & WHR Center(Kojin-kai)
Institute
Department

Funding Source
Organization Comprehensive Research on Aging and Health(Ministry of Health , Labour and Welfare)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 06 Month 13 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
2007 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2009 Year 11 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 12 Day
Last modified on
2009 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002526

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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