UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052783 |
|---|---|
| Receipt number | R000060230 |
| Scientific Title | Impact on Diabetic Foot Ulcer Formation -Attitudes toward foot care and explore the influencing factors- |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/11/13 14:27:09 |
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Basic information
Public title
Impact on Diabetic Foot Ulcer Formation
-Attitudes toward foot care and explore the influencing factors-
Acronym
Impact on Diabetic Foot Ulcer Formation
-Attitudes toward foot care and explore the influencing factors-
Scientific Title
Impact on Diabetic Foot Ulcer Formation
-Attitudes toward foot care and explore the influencing factors-
Scientific Title:Acronym
Impact on Diabetic Foot Ulcer Formation
-Attitudes toward foot care and explore the influencing factors-
Region
| Japan | Asia(except Japan) | Europe |
Condition
Condition
diabetes
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to provide nursing assistance for the prevention and improvement of diabetic foot ulcers. It aims to determine whether patients have acquired knowledge and practices of foot care and the factors that facilitate or hinder foot care in order to understand the need for assistance and appropriate methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Foot care knowledge, self-efficacy, and actual foot care behaviors of diabetic patients
Key secondary outcomes
Factors associated with continuing and discontinuing foot care
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Stage 1
Foot care knowledge, self-efficacy, and actual foot care behaviors of diabetic patients
Patients diagnosed with type 2 diabetes
Patients who are able to perform activities of daily living on their own
Patients aged 18 years and over in the countries surveyed
Content of instructions provided by nurses about diabetic foot ulcers and foot care
Nurses working in diabetes and endocrinology (either in outpatient or inpatient settings)
Stage 2
Research subjects of the interview study
Patients who agreed to be interviewed among the participants in Stage 1 of the study
Key exclusion criteria
Stage 1
None
Stage 2
None
Target sample size
732
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Takeno |
Organization
Nagoya University
Division name
Graduate School of Medicine, School of Health Sciences, Nursing department
Zip code
461-8673
Address
1-1-20, Daiko, Higashi-ku, Nagoya, Japan
TEL
052-719-1381
takeno@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Liu |
Organization
Nagoya University
Division name
Graduate School of Medicine, School of Health Sciences, Nursing department
Zip code
461-8673
Address
406 Hachiwa Building, 4-17-24, Daiko, Higashi-ku, Nagoya, Japan
TEL
070-3182-0066
Homepage URL
liu.yu.i0@s.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Lithuanian University of Health Sciences, Academy of Medicine, Faculty of Nursing, Nursing department, Lithuanian
Riau University, Faculty of Nursing, Indonesia
Guangdong Hospital of Traditional Chinese Medicine, Nursing Department, China
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University
Address
1-1-20, Daiko, Higashi-ku, Nagoya, Japan
Tel
052-719-1504
ethics@med.nagoya-u.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 | 01 | 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 | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Key outcome
Factors affecting the occurrence of diabetic foot ulcers will be identified.
Secondary outcome
Through this study, the issues that need to be resolved to prevent and improve foot ulcers will be clarified within the countries participating in the study.
Management information
Registered date
| 2023 | Year | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060230
| 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 |
