UMIN-ICDS Clinical Trial

Public title

A Study on the Efficacy of Wearing Daytime Compression Stockings
--An Open-Label Crossover Comparative Trial--

Acronym

A Study on the Efficacy of Wearing Daytime Compression Stockings

Scientific Title

A Study on the Efficacy of Wearing Daytime Compression Stockings
--An Open-Label Crossover Comparative Trial--

Scientific Title:Acronym

A Study on the Efficacy of Wearing Daytime Compression Stockings

Region

Japan

Condition

No

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate and assess the efficacy (alleviation of swelling, etc.) of wearing the test product (daytime compression stockings).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) Lower Limb Volume Measurement
2) Extracellular Water Ratio

Key secondary outcomes

* Secondary Efficacy Endpoints
1) Lower limb circumference measurements
2) Body composition measurements
3) Subjective VAS questionaire

* Safety Endpoints
1) Physician interview/physical examination/adverse event assessment
2) Blood pressure and pulse measurements
3) Daily activity log

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

[1] Wearing the test product (single use, prolonged sitting test)
[2] Measurement
[3] Washout period (6 days or more)
[4] Not wearing the test product (prolonged sitting test)
[5] Measurement

Interventions/Control_2

[1] Not wearing the test product (prolonged sitting test)
[2] Measurement
[3] Washout period (6 days or more)
[4] Wearing the test product (single use, prolonged sitting test)
[5] Measurement

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

18

years-old

<=

Age-upper limit

60

years-old

>

Gender

Female

Key inclusion criteria

1) Women aged 18 or older but under 60 at the time of obtaining consent to participate in the study.
2) Individuals with a BMI of 18.5 kg/m2 or higher but less than 25.0 kg/m2.
3) Individuals whose leg swelling does not subside upon waking (e.g., marks from socks or similar items tend to remain).
4) Individuals who agree not to use any swelling-relief therapies-such as massage devices or other compression socks during the study period.
5) Healthy individuals with no chronic physical conditions, including skin diseases.
6) Individuals whose daily routines will not become irregular from one week before the test until the test is completed.
7) Individuals who consent to the use of the test results in academic society publications or corporate advertisements in a form that does not identify specific individuals.
8) Individuals who have received a thorough explanation of the purpose and content of this trial, possess the capacity to give informed consent, have voluntarily applied to participate after fully understanding the details, and are able to provide written consent to participate in this trial.
9) Individuals who are able to visit the facility on the designated examination date, strictly adhere to the guidelines, and undergo the examination.
10) Individuals whom the principal investigator deems suitable for participation in this trial.

Key exclusion criteria

Individuals
1) with chronic diseases or those currently undergoing treatment for any medical condition.
2) with a current or clinically significant history of arterial circulatory disorders, congestive heart failure, painful phlegmasia, infectious phlebitis, deep vein thrombosis, chronic fatigue syndrome, mental or sleep disorders, hypertension, diabetes, dyslipidemia, lower extremity varicose veins, or lumbar spinal stenosis.
3) with a current or past history of severe conditions affecting the liver, kidneys, heart, lungs, blood, or digestive system.
4) with severe anemia.
5) with symptoms of skin conditions such as atopic dermatitis.
6) with metal allergies or hypersensitivity to fibers.
7) with severe leg deformities, lower limb disorders, inflammatory or suppurative diseases, acute wounds or inflammation, or sensory or neurological disorders.
8) taking oral contraceptives.
9) who have taken or applied medication for the treatment of a medical condition within the past month.
10) who routinely use elastic stockings, compression socks, or calf supports in their daily lives.
11) currently or recently (within 1 month) consuming FOSHU, foods with functional claims, or health foods, and those planning to consume them during the study.
12) whose daily alcohol consumption, calculated as pure alcohol, exceeds an average of 20 g per day.
13) who smoke.
14) who engage in high-intensity exercise on a regular basis and those who are currently dieting.
15) Night shift workers.
16) who are pregnant, breastfeeding, or who may become pregnant during the study.
17) with irregular lifestyle or dietary habits, or those likely to change their lifestyle during the study.
18) currently participating in another human clinical trial, or who participated in one within the past month.
19) Any other individuals deemed ineligible for this trial by the principal investigator.

Target sample size

25

Name of lead principal investigator

1st name	Takao
Middle name
Last name	Muto

Organization

MTG Co.,Ltd.

Division name

Academic Planning Division

Zip code

453-0041

Address

MTG No. 2 HIKARI Building, 4-13 Honjintori, Nakamura-ku, Nagoya City, Aichi, 453-0041 Japan

TEL

+81-80-5290-6753

Email

takao.muto@mtg.gr.jp

Name of contact person

1st name	Ryoma
Middle name
Last name	Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

MTG Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81-3-6240-1162

Email

jimukyoku@tes-h.co.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

2026

Year

07

Month

22

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

2026

Year

07

Month

07

Day

Date of IRB

2026

Year

07

Month

08

Day

Anticipated trial start date

2026

Year

07

Month

23

Day

Last follow-up date

2026

Year

07

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

07

Month

22

Day

Last modified on

2026

Year

07

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071160