UMIN-CTR Clinical Trial

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

Lower limb edema.

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hamamatsu University School of Medicine Hospital rehabilitation department

Institute

Department

Personal name

Organization

Hamamatsu University School of Medicine Hospital rehabilitation department

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

10

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

10

Month

12

Day

Last modified on

2020

Year

10

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047812