UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019383 |
|---|---|
| Receipt number | R000021530 |
| Scientific Title | Prospective observational study for effect of oral nutrition supplement on pressure ulcer healing |
| Date of disclosure of the study information | 2015/10/19 |
| Last modified on | 2017/10/03 10:40:33 |
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Basic information
Public title
Prospective observational study for effect of oral nutrition supplement on pressure ulcer healing
Acronym
Study for the nutrition supplement on pressure ulcer healing
Scientific Title
Prospective observational study for effect of oral nutrition supplement on pressure ulcer healing
Scientific Title:Acronym
Study for the nutrition supplement on pressure ulcer healing
Region
| Japan |
Condition
Condition
Pressure ulcer
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between nutrition and pressure ulcer healing by evaluatiopn the intake of oral nutrition supplements and nutritional status of the patients with pressure ulcer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of pressure ulcer healing assessed by DESIGN-R score
Key secondary outcomes
a. The rate of nutritional improvement assessed by CONUT score
b. Feasibility of oral nutritional supplements
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1. Manageable pressure ulcer
2. Suppliable oral nutrition supplements
3. Hospital stay more than 2 weeks
Key exclusion criteria
1. Unmanageable pressure ulcer
2. Unable to supply oral nutrition supplements
3. Hospital stay within 2 weeks
4. Intubation at enrollment
5. Under 20 year old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fuyuhiko Motoi |
Organization
Tohoku University
Division name
Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
fmotoi@surg1med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuyuhiko Motoi |
Organization
Tohoku University
Division name
Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
Homepage URL
http://www.med.tohoku.ac.jp/public/ekigaku.html
fmotoi@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Nutrition Support Center and Wound Ostomy Continence (WOC) Center, Nursing Department of Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Tohoku University
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
| 2015 | Year | 10 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | 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
Study design: Cohort study (Observational, Prospective)
Study population: Patients with Pressure Ulcer who enter Tohoku University Hospital between Nov 1, 2015 and Oct 31, 2020, and meet all the inclusion criteria (Target sample size is 100).
Management information
Registered date
| 2015 | Year | 10 | Month | 16 | Day |
Last modified on
| 2017 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021530
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
