UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005860 |
|---|---|
| Receipt number | R000006923 |
| Scientific Title | A non-randomized controlled trial examining effects of zinc-containing preparation polaprezinc on pressure ulcer healing |
| Date of disclosure of the study information | 2011/06/28 |
| Last modified on | 2016/11/14 23:10:29 |
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Basic information
Public title
A non-randomized controlled trial examining effects of zinc-containing preparation polaprezinc on pressure ulcer healing
Acronym
Effects of zinc-containing preparation polaprezinc on pressure ulcer healing
Scientific Title
A non-randomized controlled trial examining effects of zinc-containing preparation polaprezinc on pressure ulcer healing
Scientific Title:Acronym
Effects of zinc-containing preparation polaprezinc on pressure ulcer healing
Region
| Japan |
Condition
Condition
Pressure ulcer
Classification by specialty
| Surgery in general | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine and compare the effects of zinc-containing preparation polaprezinc and its subcomponent L-carnosine on the healing of chronic pressure ulcers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in PUSH (Pressure Ulcer Scale for Healing) score
Key secondary outcomes
Body weight, Biochemistry, Dietary intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After 4-week untreated period, polaprezinc is administered orally at a dose of 75 mg twice a day until complete healing or for a maximum of 8 weeks.
Interventions/Control_2
Polaprezinc is administered orally at a dose of 75 mg twice a day until complete healing or for a maximum of 8 weeks.
Interventions/Control_3
L-Carnosine is administered orally at a dose of 58 mg twice a day until complete healing or for a maximum of 4 weeks. For patients without complete healing within 4 weeks, from the end of 4-week period, polaprezinc is administered orally at a dose of 75 mg twice a day until complete healing or for a maximum of 8 weeks.
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
Patients who meet following requirements:
1) aged 20 and older
2) at least one stage 2, 3, or 4 chronic pressure ulcer according to the revised National Pressure Ulcer Advisory Panel (NPUAP) classification system
3) an estimated surface area of one ulcer is 24 square centimeters or less, as calculated with the formula: greatest length (head to toe) multiplied by greatest width (side to side) of the ulcer
4) patients who take a diet orally
5) written informed consent from patients and their families before registration to this study
Key exclusion criteria
1) a clinical suspicion or diagnosis of osteomyelitis
2) diabetes mellitus
3) peripheral vascular disease
4) neoplastic disease
5) acute illness (e.g., infection)
6) other severe diseases
7) patients who receive tube or parenteral feeding
8) use of steroids
9) patients who are in the terminal phase of their illness
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensaku Sakae |
Organization
The Jikei University School of Medicine
Division name
Department of Public Health and Environmental Medicine
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo
TEL
03-3433-1111(ext.2266)
yashiohp@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensaku Sakae |
Organization
The Jikei University School of Medicine
Division name
Department of Public Health and Environmental Medicine
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo
TEL
03-3433-1111(ext.2266)
Homepage URL
yashiohp@nifty.com
Sponsor or person
Institute
Department of Public Health and Environmental Medicine, The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
医療法人慶榮会 八潮病院 （埼玉県）
特別養護老人ホーム 杜の家やしお （埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 28 | Day |
Last modified on
| 2016 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006923
