UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of elastic stocking on the leg lymph function assessed by indocyanine-green-fluorescence lymph vessel imaging
Title of the study (Brief title)	Assessment of the effect of elastic stocking on lymph pumping pressure and general health performance
Region	Japan

Condition
Condition	Perturbance of lymph perfusion
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of the effect of elastic stocking on lymph pumping pressure and general health performance
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	indocyanine green fluorescence lymphography, lymphatic pumping pressure SF-36 interview
Key secondary outcomes

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Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Recrute healthy volunteers with leg lymph pumping less than 20 mmHg lymph ejection pressure fell to 20 or less mmHg. Test the effect of elastic stocking on the improvement of leg lymph pumping and general health condition after 4 months.
Interventions/Control_2	Control group with non elastic stocking
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	70 years-old >=
Gender	Female
Key inclusion criteria	healthy volunteers whom lymph ejection pressure fell to 20 or less mmHg
Key exclusion criteria	chronic venous insufficiency (CVI) such as varicose vein and deep vein thrombosis, People with past medical history of leg injury, patients with secondary lymphedema (pelvic surgery such as uterus, prostate, and rectal surgery)
Target sample size	100

Research contact person
Name of lead principal investigator	Naoki Unno
Organization	Hamamatsu University School of Medicine
Division name	Vascular surgery
Address	Hamamatsu University School of Medicine,1-20-1Handayama,Higashi-ku,Hamamatsu-shi, Shizuoka, 431-3125, Japan
TEL	053-435-2273
Email	r.sugisawa@gmail.com

Public contact
Name of contact person	Ryota Sugisawa
Organization	Hamamatsu University School of Medicine,
Division name	Vascular surgery
Address	Hamamatsu University School of Medicine,1-20-1Handayama,Higashi-ku,Hamamatsu-shi, Shizuoka, 431-3125
TEL	053-435-2273
Homepage URL
Email	r.sugisawa@gmail.com

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Toray Opelontex Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2012 Year 10 Month 22 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 10 Month 01 Day
Anticipated trial start date	2012 Year 11 Month 01 Day
Last follow-up date	2014 Year 03 Month 31 Day
Date of closure to data entry	2014 Year 03 Month 31 Day
Date trial data considered complete	2014 Year 03 Month 31 Day
Date analysis concluded	2014 Year 03 Month 31 Day

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

Management information
Registered date	2012 Year 10 Month 19 Day
Last modified on	2016 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010725