UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the correlation among the changes in extremity volume, extracellular fluid volume, and subcutaneous inflammatory change in the legs with edema
Title of the study (Brief title)	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	Kimikazu Hamano
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Surgery and Clinical Science
Address	1-1-1 Minamikogushi, Ube, Yamaguchi
TEL	0836-22-2261
Email	surg-1@yamaguchi-u.ac.jp

Public contact
Name of contact person	Kotaro Suehiro
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Surgery and Clinical Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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