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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020447
Receipt No. 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

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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
Email 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
Email ksuehiro-circ@umin.ac.jp

Sponsor
Institute Department of Surgery and Clinical Science
Yamaguchi University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023627

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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