UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033562 |
|---|---|
| Receipt number | R000038275 |
| Scientific Title | Investigation of the effects of foot care on self-care and related factors in diabetic patients. |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2024/08/17 00:22:39 |
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Basic information
Public title
Investigation of the effects of foot care on self-care and related factors in diabetic patients.
Acronym
Investigation of the effects of foot care on self-care and related factors in diabetic patients.
Scientific Title
Investigation of the effects of foot care on self-care and related factors in diabetic patients.
Scientific Title:Acronym
Investigation of the effects of foot care on self-care and related factors in diabetic patients.
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to investigate the effects of foot care on self-care and related factors in diabetic patients in order to enhance support and guidance for them.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After providing foot care to diabetic patients, a questionnaire is conducted to investigate in their self-care.
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention includes; 1)offering a footbath and trimming nails, 2) checking vibration perception and pressure sensation in the foot, and 3) checking whether each patient's goal of foot care is achieved. The intervention is 30 minutes long and is offered once a month for 6 months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are judged to require foot care by their doctors.
Key exclusion criteria
Patients who cannot answer the questionnaire.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ayami |
| Middle name | |
| Last name | Hayashi |
Organization
Fukushima Medical University School of Nursing
Division name
Department of Fundamental Nursing
Zip code
9601295
Address
1 Hikarigaoka, Fukushima-shi, Fukushima ,Japan
TEL
024-547-1865
yami@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Ayami |
| Middle name | |
| Last name | Hayashi |
Organization
Fukushima Medical University School of Nursing
Division name
Department of Fundamental Nursing
Zip code
9601295
Address
1 Hikarigaoka, Fukushima-shi, Fukushima ,Japan
TEL
024-547-1865
Homepage URL
yami@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical 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
Fukushima Medical University School of Nursing
Address
1 Hikarigaoka, Fukushima-shi, Fukushima ,Japan
Tel
024-547-1865
yami@fmu.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
| 2018 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the impact of COVID-19, the number of patients could not be gathered.
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
| 2018 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038275
