UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051204 |
|---|---|
| Receipt number | R000058399 |
| Scientific Title | Anatomy of dorsomedial cutaneous nerve to hallux using ultrasonography |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/05/31 12:56:29 |
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Basic information
Public title
Anatomy of the dorsomedial cutaneous nerve to hallux using ultrasonography
Acronym
Anatomy of the hallux dorsomedial cutaneous nerve
Scientific Title
Anatomy of dorsomedial cutaneous nerve to hallux using ultrasonography
Scientific Title:Acronym
Anatomy of hallux dorsomedial cutaneous nerve
Region
| Japan |
Condition
Condition
Hallux valgus
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the anatomy of the dorsomedial cutaneous nerve to hallux using ultrasonography
Basic objectives2
Others
Basic objectives -Others
To measure the distances between the anatomical landmarks of the hallux to the dorsomedial cutaneous nerve
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distance from the medial center of the first metatarsal to the dorsomedial cutaneous nerve
Key secondary outcomes
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultrasonography
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with hallux valgus who visit the outpatient orthopedic clinic of Chiba University Hospital
2) Hallux valgus angle of 15 degrees or more
Key exclusion criteria
1) Under 18 years of age
2) History of foot or ankle surgery
3) History of foot or ankle fracture
4) Joint destruction of the hallux due to tumor and inflammatory disease
5) Disagreement to participate in the study
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Chiba University
Division name
Graduate School of Global and Transdisciplinary Studies
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2117
y-satoshi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Chiba University
Division name
Graduate School of Global and Transdisciplinary Studies
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-226-2117
Homepage URL
y-satoshi@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Research ethics committee of the graduate school of medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-226-2462
igaku-rinri@office.chiba-u.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
| 2023 | Year | 07 | Month | 01 | 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
| 2023 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | 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
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058399
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
