UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056591 |
|---|---|
| Receipt number | R000064673 |
| Scientific Title | Verification of the Edema Reduction Effect of Compression Tights: A Crossover Study |
| Date of disclosure of the study information | 2024/12/27 |
| Last modified on | 2025/04/09 10:27:25 |
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Basic information
Public title
Verification of the Edema Reduction Effect of Compression Tights: A Crossover Study
Acronym
Verification of the Edema Reduction Effect of Compression Tights: A Crossover Study
Scientific Title
Verification of the Edema Reduction Effect of Compression Tights: A Crossover Study
Scientific Title:Acronym
Verification of the Edema Reduction Effect of Compression Tights: A Crossover Study
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of compression tights on edema in adult women and to clarify the evidence of their preventive effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement of morning edema from wearing compression tights will be assessed by measuring the thighs, calves, and ankles with a tape measure.
Key secondary outcomes
The impact of wearing compression tights on fatigue and sleep will be assessed using the NRS and OSA-MA.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention group: After a 1-week acclimatization period of wearing thigh-length compression tights during the day, they will be worn every night before sleep for the following week.
Interventions/Control_2
Control group: No compression tights will be worn, and participants will sleep every night for 2 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 28 | years-old | > |
Gender
Female
Key inclusion criteria
The individuals who have received sufficient explanation about the purpose and content of this study, have the capacity to consent, fully understand the details, voluntarily volunteered, and have provided written consent, and who are aware of having edema.
Key exclusion criteria
The exclusion criteria for participation in the study are as follows:
1. Individuals who have refused to participate in the study based on their own decision.
2. Individuals with severe arterial circulation disorders, congestive heart failure, post-skin grafts, necrosis or edema, or purulent skin diseases.
3. Individuals with infectious phlebitis.
4. Individuals with extreme leg deformities.
5. Individuals deemed ineligible by the judgment of the principal investigator.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
n-wakui@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Practical Education and Research Division
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
Homepage URL
n-wakui@hoshi.ac.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Funding Source
Organization
Hoshi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Hoshi Pharmacy University
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
Tel
03-3786-1011
y-hashiguchi@hoshi.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
| 2024 | Year | 12 | Month | 27 | 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
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064673
