UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037443 |
|---|---|
| Receipt number | R000042679 |
| Scientific Title | The effect of visit instruction for recurrence prevention after discharge on diabetes foot patient |
| Date of disclosure of the study information | 2019/07/26 |
| Last modified on | 2022/01/21 12:08:02 |
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Basic information
Public title
The effect of visit instruction for recurrence prevention after discharge on diabetes foot patient
Acronym
The effect of visit instruction for recurrence prevention after discharge on diabetes foot patient
Scientific Title
The effect of visit instruction for recurrence prevention after discharge on diabetes foot patient
Scientific Title:Acronym
The effect of visit instruction for recurrence prevention after discharge on diabetes foot patient
Region
| Japan |
Condition
Condition
diabetic foot
peripheral arterial disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of visit instruction for recurrence prevention after discharge on diabetes foot patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of recurrence for wounds
Key secondary outcomes
Range of Motion (Ankle Joint)
Lower limb strength
Size of wounds
Plantar load of walking
QOL(EQ-5D-5L)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
visit instruction by the therapist
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
admitted to the hospital for treatment of diabetic foot ulcers and discharged at home
Key exclusion criteria
patients who do not agree to this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Imaoka |
Organization
Oitaoka Hospital
Division name
Department of Rehabilitation
Zip code
870-0192
Address
Nishitsurusaki oita city Japan 3-7-11
TEL
097-522-3131
ptssinnsukeimaoka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Imaoka |
Organization
Oitaoka Hospital
Division name
Department of Rehabilitation
Zip code
852-8102
Address
Nishitsurusaki oita city Japan 3-7-11
TEL
097-522-3131
Homepage URL
ptssinnsukeimaoka@yahoo.co.jp
Sponsor or person
Institute
Oitaoka 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
Oitaoka Hospital
Address
Nishitsurusaki oita city Japan 3-7-11
Tel
097-522-3131
ptssinnsukeimaoka@yahoo.co.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
| 2019 | Year | 07 | Month | 26 | 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
46
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 07 | Month | 21 | Day |
Last modified on
| 2022 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042679
| 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 |
