UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002072 |
|---|---|
| Receipt number | 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 13:24:44 |
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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
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
Sponsor or person
Institute
Pressure Ulcer & WHR Center(Kojin-kai)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002526
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
