UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058511 |
|---|---|
| Receipt number | R000066891 |
| Scientific Title | Development of nursing education program for assessment of tinea pedis or unguium to prevent diabetic foot ulcer |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/07/18 09:58:40 |
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Basic information
Public title
Development of nursing education program for assessment of tinea pedis or unguium
Acronym
Development of nursing education program for assessment of tinea pedis or unguium
Scientific Title
Development of nursing education program for assessment of tinea pedis or unguium to prevent diabetic foot ulcer
Scientific Title:Acronym
Development of nursing education program for assessment of tinea pedis or unguium to prevent diabetic foot ulcer
Region
| Japan |
Condition
Condition
Patients with diabetes mellitus presenting with suspected tinea pedis and unguium.
Classification by specialty
| Endocrinology and Metabolism | Dermatology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop and evaluate a nursing education program for direct microscopy, to enable nurses to accurately identify tinea pedis and onychomycosis, which are risk factors for diabetic foot ulcers.
Basic objectives2
Others
Basic objectives -Others
goal achievement level
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The score of written and practical examination
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
An educational program intervention will be conducted about tinea pedis and unguium assessment with direct microscopy.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Nurses who works in foot care clinic and provided written informed consent based on their free will after receiving sufficient explanation and achieving adequate understanding will participate in this study.
Key exclusion criteria
Nurses who have experience conducting direct microscopy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takehara |
| Middle name | |
| Last name | Kimie |
Organization
Fujita Health University
Division name
Faculty of Nursing, School of Health Sciences
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562932554
kimie.takehara@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Naito |
| Middle name | |
| Last name | Chihiro |
Organization
Fujita Health University
Division name
Department of Health Sciences, Graduate School of Health Sciences
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
TEL
0562932554
Homepage URL
82024114@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita health university
Institute
Department
Personal name
Takehara Kimie
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University Institutional Review Board
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
Tel
0562932865
f-irb@fujita-hu.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
藤田医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 20 | 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
| 2025 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 18 | Day |
Last modified on
| 2025 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066891
