UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020447 |
|---|---|
| Receipt number | R000023627 |
| Scientific Title | Study on the correlation among the changes in extremity volume, extracellular fluid volume, and subcutaneous inflammatory change in the legs with edema |
| Date of disclosure of the study information | 2016/01/06 |
| Last modified on | 2017/01/05 17:46:09 |
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Basic information
Public title
Study on the correlation among the changes in extremity volume, extracellular fluid volume, and subcutaneous inflammatory change in the legs with edema
Acronym
Correlation between the changes in leg volume and extracellular fluid volume
Scientific Title
Study on the correlation among the changes in extremity volume, extracellular fluid volume, and subcutaneous inflammatory change in the legs with edema
Scientific Title:Acronym
Correlation between the changes in leg volume and extracellular fluid volume
Region
| Japan |
Condition
Condition
Phlebolymphology
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how the changes in interstitial fluid volume and inflammatory tissue proliferation affect the change in leg volume.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in bioelectrical impedance of legs in 6-12 months time.
Key secondary outcomes
The changes in leg circumferences and subcutaneous ultrasonography findings of legs in 6-12 months time.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Bioelectrical impedance analysis
Device:L-Dex U400 (Impedimed, Ltd, Austraria)
Term: Feb,2016 - Mar,2018
Frequency: twice per patient
(initial measurement and second
measurement at 12 months)
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
The patients with leg edema witout systemic diseases that may cause leg edema.
Key exclusion criteria
Those whom investigators decide to be excluded because of mental and/or physical problems.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimikazu Hamano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
0836-22-2261
surg-1@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Suehiro |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi
TEL
0836-22-2261
Homepage URL
ksuehiro-circ@umin.ac.jp
Sponsor or person
Institute
Department of Surgery and Clinical Science
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate 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
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
| 2016 | Year | 01 | Month | 06 | 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
| 2015 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 06 | 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
| 2016 | Year | 01 | Month | 06 | Day |
Last modified on
| 2017 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023627
