UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007857 |
|---|---|
| Receipt number | R000009255 |
| Scientific Title | Randomized-controlled trial comparing effects of zinc-containing preparation and nutritonal intervention to treatment of pressure ulcer |
| Date of disclosure of the study information | 2012/04/28 |
| Last modified on | 2012/04/28 13:45:04 |
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Basic information
Public title
Randomized-controlled trial comparing effects of zinc-containing preparation and nutritonal intervention to treatment of pressure ulcer
Acronym
Randomized-controlled trial comparing effects of zinc-containing preparation and nutritonal intervention to treatment of pressure ulcer
Scientific Title
Randomized-controlled trial comparing effects of zinc-containing preparation and nutritonal intervention to treatment of pressure ulcer
Scientific Title:Acronym
Randomized-controlled trial comparing effects of zinc-containing preparation and nutritonal intervention to treatment of pressure ulcer
Region
| Japan |
Condition
Condition
Pressure ulcer
Classification by specialty
| Dermatology | Plastic surgery | Laboratory medicine |
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of zinc-contained preparation and nutritional intervention to healing pressure ulcer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The condition of pressuer ulcer(reduction of DESIGN-R score)
Key secondary outcomes
Time course of change a trace elements in serum
Time course of change in serum hydroxyproline
Nutitional condition(clinical laboratory test results)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Grop of intervention by Zinc-containing preparation
Interventions/Control_2
Group of intervention by Nutition
Interventions/Control_3
Control group
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)aged 40 and older.
2)Region of pressure ulcer must be sacrum, coccyx, and greater trochanter. The stage must be more than 2(NPUAP).
3)In case of the pressure ulcer with necrotic tissue, the necroic tissue must been debridement.
4)The depth of pocket of pressure ulcer must be less than 2cm.
Key exclusion criteria
1)Acute illness (e.g. infection)
2)Collergen disease, rheumatoid arthritis, severe liver cirrhosis, neoplastic disease.
3)Patients with more than 3 stage 2 to 4(NPUAP) pressure ulcer.
4)Patients who determine inappropriate to enroll clinical study by
investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kozo Yamamoto M.D. |
Organization
International University of Health and Welfare Mita Hospital
Division name
Department of Dermatology
Zip code
Address
1-4-3, Mita, Minato-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
International University of Health and Welfare Mita Hospital
Division name
Department of Dermatology
Zip code
Address
1-4-3, Mita, Minato-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
International University of Health and Welfare Mita Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 04 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | 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
| 2012 | Year | 04 | Month | 28 | Day |
Last modified on
| 2012 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009255
| 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 |
