UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055103 |
|---|---|
| Receipt number | R000062951 |
| Scientific Title | Effects of shoe insoles with five levels of metatarsal support on the feet : single blinded study |
| Date of disclosure of the study information | 2024/07/30 |
| Last modified on | 2025/01/27 10:48:43 |
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Basic information
Public title
Effects of shoe insoles with five levels of metatarsal support on the feet
Acronym
insoles study
Scientific Title
Effects of shoe insoles with five levels of metatarsal support on the feet : single blinded study
Scientific Title:Acronym
Effects of shoe insoles with five levels of metatarsal support on the feet
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate changes in foot condition when using the test article for 12 weeks when going out.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS, WIQ
Key secondary outcomes
subjective assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use the test article when out and about for 12 week
Interventions/Control_2
Life as usual for a certain period of time
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
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Subjects who frequently feel foot fatigue or have flat feet
2.Subjects who stand or walk for more than 5 hours a day, and do so more than 5 days a week
3.Subjects who walk more than 5,000 steps a day
Key exclusion criteria
1. Subjects or breast-feeding women.
2. Subjects who spend less than 5 hours per day wearing shoes (sandals or other non-shoe footwear).
3. Subjects who do not experience foot fatigue.
4. Subjects who are undergoing a hospital visit or treatment regarding their feet/legs, or who have undergone foot surgery in the past
5. Subjects with serious foot pain or disability.
6. Subjects who are already using other insoles or corrective shoes.
7. Subjects with serious heart, respiratory, circulatory or other serious health problems
8. Subjects with foot injuries or disorders that limit their mobility
9. Subjects using certain medications that affect foot conditions
10. Subjects who have participated or are currently participating in other human trials within one month
11. other persons deemed inappropriate by the responsible physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
Iwamizu Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
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 | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
21
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 | 07 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 22 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062951
