UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051327 |
|---|---|
| Receipt number | R000058478 |
| Scientific Title | Evaluation of the Effectiveness of Educational Instructional Methods on the Prevention of Severe Foot Disease in Patients with Diabetic Foot Lesions |
| Date of disclosure of the study information | 2023/06/12 |
| Last modified on | 2024/12/12 15:24:21 |
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Basic information
Public title
Evaluation of the Effectiveness of Educational Instructional Methods on the Prevention of Severe Foot Disease in Patients with Diabetic Foot Lesions
Acronym
Evaluation of the Effectiveness of Educational Instructional Methods on the Prevention of Severe Foot Disease in Patients with Diabetic Foot Lesions
Scientific Title
Evaluation of the Effectiveness of Educational Instructional Methods on the Prevention of Severe Foot Disease in Patients with Diabetic Foot Lesions
Scientific Title:Acronym
Evaluation of the Effectiveness of Educational Instructional Methods on the Prevention of Severe Foot Disease in Patients with Diabetic Foot Lesions
Region
| Japan |
Condition
Condition
Diabetic foot disease change patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of educational intervention on prevention of recurrence in patients with diabetic foot lesions from the early stage of hospitalization and to support the prevention of recurrence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trauma re-injury rate (within 6 months after discharge from hospital)
Key secondary outcomes
(1)Geriatric Depression Scale (GDS-5)
(2)International Physical Activity Questionnaire (IPAQ)
(3) Problem Areas in Diabetes Survey
(4) Range of motion of foot joints
(5) Gait ability (6) Lower limb muscle strength
(6) Lower limb muscle strength
(7) Skin perfusion pressure (SPP)
(8)Body mass index (BMI)
(9)Blood glucose control (HbA1c)
(10) Presence or absence of dialysis
(11) Footwear compliance rate
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
In the intervention group, participants will watch video content on wound deterioration, check their understanding through quizzes, and receive feedback on the results for 15 minutes per day, 5 times per week for 1 week. I
Interventions/Control_2
n the control group, general verbal instruction will be given at the time of discharge from the hospital. The subjects are randomly assigned to the intervention group (educational instruction using tablets) or the control group (ordinary instruction) using the RAND function in Excel (Microsoft Corporation), and the assignment results are not disclosed to the subjects.
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
(Selection Criteria)
Those who are hospitalized and undergo rehabilitation for the purpose of treatment of diabetic foot lesions.
Key exclusion criteria
(Exclusion Criteria)
Persons who have undergone amputation of the lower leg or foot.
Those who are unable to understand the purpose of the study due to significant cognitive or mental impairment.
Those who have difficulty in continuous rehabilitation due to unstable wound or general condition.
Those who require assistance with all ADLs due to visual impairment.
Persons who are judged to be ineligible by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | minata |
| Middle name | |
| Last name | shohei |
Organization
Oita Oka Hospital
Division name
Department of Rehabilitation
Zip code
870-0192
Address
3-7-11 Nishi-Tsuruzaki, Oita City, Oita Prefecture
TEL
097-522-3131
minatasyohei@gmail.com
Public contact
Name of contact person
| 1st name | minata |
| Middle name | |
| Last name | shohei |
Organization
Oita Oka Hospital
Division name
Department of Rehabilitation
Zip code
870-0192
Address
3-7-11 Nishi-Tsuruzaki, Oita City, Oita Prefecture
TEL
097-522-3131
Homepage URL
minatasyohei@gmail.com
Sponsor or person
Institute
oita oka hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
oita oka hospital
Address
3-7-11 Nishi-Tsuruzaki, Oita City, Oita Prefecture
Tel
097-522-3131
minatasyohei@gmail.com
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 | 06 | Month | 12 | 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
37
Results
Physical function tests showed limitation in ankle dorsiflexion angle and knee extension muscle strength. The recurrence rate was 24.3%, and the time to recurrence was 45.0 (31.0-95.0) days. Patients with recurrence had more diabetic complications and had difficulty self-managing due to visual and sensory impairments. The importance of a support system and the inconvenience of accessibility should be taken into account in providing guidance.
Results date posted
| 2024 | Year | 06 | Month | 14 | Day |
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
Main results already published
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | 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
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 12 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058478
