UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032921 |
|---|---|
| Receipt number | R000037532 |
| Scientific Title | An evaluation of pressure ulcer using fingerstall-type tissue oximetry |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2020/03/11 09:31:18 |
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Basic information
Public title
An evaluation of pressure ulcer using fingerstall-type tissue oximetry
Acronym
Evaluation of pressure ulcer using fingerstall-type tissue oximetry
Scientific Title
An evaluation of pressure ulcer using fingerstall-type tissue oximetry
Scientific Title:Acronym
Evaluation of pressure ulcer using fingerstall-type tissue oximetry
Region
| Japan |
Condition
Condition
Pressure ulcer
Classification by specialty
| Plastic surgery | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To get regional tissue oxygen saturation and total hemoglobin index in the pressure ulcer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Regional tissue oxygen saturation and total hemoglobin index in the pressure ulcer
Key secondary outcomes
The relationship between the regional tissue oxygen saturation and total hemoglobin index and healing process in the pressure ulcer
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Assessment of regional saturation of oxygen and total hemoglobin index in the pressure ulcer by the finger-mounted near-infrared spectroscopy
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with pressure ulcer
Key exclusion criteria
Unsuited patients for investigation such as severe infection and shock
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Fukamizu |
Organization
Hamamatsu University School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
4313192
Address
1-20-1 Handayama higashi-ku Hamamatsu, Japan
TEL
053-435-2155
fukamizu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Fukamizu |
Organization
Hamamatsu University School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
4313192
Address
1-20-1 Handayama higashi-ku Hamamatsu, Japan
TEL
053-435-2155
Homepage URL
fukamizu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama higashi-ku Hamamatsu, Japan
Tel
053-435-2155
fukamizu@hama-med.acjp
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
| 2018 | Year | 07 | Month | 01 | 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
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 08 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037532
