UMIN-CTR Clinical Trial

Basic information
Public title	A study investigating how to measure lower limb edema.
Acronym	Study of lower limb edema.
Scientific Title	Prospective intervention study aimed at establishing a circumference measurement method for lower limb lymphedema.
Scientific Title:Acronym	Study of lower limb lymphedema.
Region	Japan

Condition
Condition	Lower limb edema.
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The most effective circumference measurement will be clarified by comparing the volume and circumference calculated by Perometer with the volume and circumference of each of the 5-point and 10-point manual circumferential measurement for patients with lower limb edema.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The lower limb volume measured by the Perometer on the same day and at the same time is compared with the lower limb volume calculated by the 5-point method of the circumference measurement method and the lower limb volume calculated by the 10-point method, and the correlation and error are tested.
Key secondary outcomes	Compare the perimeter of the lower limbs measured by the perometer with the perimeter of the lower limbs measured by the 5-point and 10-point methods.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Using a perometer that measures the volume by irradiating the lower limbs with infrared rays, the circumference of the lower limbs and the volume of the lower limbs are measured in 80 cases. Subjects rest for 15 minutes before making measurements. Subjects are instructed to avoid strenuous exercise and alcohol consumption 24 hours before the measurement and to limit eating and drinking 1 hour before the start of the measurement.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who can take a standing posture. Those who have obtained consent for this research by signing the consent form by the person himself / herself.
Key exclusion criteria	Patients with deep vein thrombosis Patients with serious heart disease Persons with serious liver disease (or persons with AST 100U/L or less) Persons with severe renal disease (or serum creatinine 1.3mg/dl or higher) Women who are pregnant or may become pregnant Patients with a pacemaker Patients with venous disease
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Sano
Organization	Hamamatsu University School of Medicine Hospital
Division name	Second Surgery Department Group
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL	053-435-2111
Email	m.sano@hama-med.ac.jp

Public contact
Name of contact person	1st name Yurina Middle name Last name Yokoyama
Organization	Hamamatsu University School of Medicine Hospital
Division name	Rehabilitation department
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL	053-435-2747
Homepage URL
Email	yrn.hashimoto.0619@gmail.com

Sponsor
Institute	Hamamatsu University School of Medicine Hospital rehabilitation department
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine Hospital rehabilitation department
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	Ethics Committee of Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
Tel	053-435-2680
Email	rinri@hama-med.ac.jp

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	2020 Year 10 Month 19 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	Preinitiation
Date of protocol fixation	2020 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date	2020 Year 10 Month 19 Day
Last follow-up date	2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 12 Day
Last modified on	2020 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047812