UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007857
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute International University of Health and Welfare Mita Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009255

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.