UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039012 |
|---|---|
| Receipt number | R000044485 |
| Scientific Title | The effects of introducing a diabetic foot clinic on the occurrence of diabetic foot in Indonesia |
| Date of disclosure of the study information | 2019/12/27 |
| Last modified on | 2022/12/28 09:40:25 |
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Basic information
Public title
The effects of introducing a diabetic foot clinic on the occurrence of diabetic foot in Indonesia
Acronym
The effects of introducing a diabetic foot clinic on the occurrence of diabetic foot in Indonesia
Scientific Title
The effects of introducing a diabetic foot clinic on the occurrence of diabetic foot in Indonesia
Scientific Title:Acronym
The effects of introducing a diabetic foot clinic on the occurrence of diabetic foot in Indonesia
Region
| Asia(except Japan) |
Condition
Condition
Diabetic foot ulcer
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of an Indonesian version diabetic foot clinic protocol on preventing diabetic foot ulcer in patients with a diabetic foot ulcer history.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Diabetic foot ulcer occurrence after 6 months follow-up
Key secondary outcomes
The severity of ulceration, change of foot care behavior, change of QoL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Provide examinations to detect the potential risk of ulceration, then provide foot care and education to patients who visit diabetic foot clinic.Intervention group will be divided into two groups, non-ulcerative pathology with inflammation group and non-inflammation group. For patients with inflammation, nurse provide foot care once per month. For those without inflammation, the nurse will ask patients to do annual check-ups. For research purposes, nurses will visit participants' homes to check on whether ulceration occurs.
Interventions/Control_2
For control group, nurse will provide the usual care.For research purposes, nurses will visit participants' homes to check on whether ulceration occurs.
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
Diabetic patients with ulceration history
Key exclusion criteria
Currently, have foot ulcer; patients that had major amputation; patients that can not finish 6 months follow up period; healthy conditions not fit in this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Sanada |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
Med-5th Bldg. 7-3-1 Hongo, Bunkyo-The intervention, Tokyo 113-0033 JAPAN
TEL
03-5841-3419
hsanada-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Qi |
| Middle name | QI |
| Last name | Qin |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
1130033
Address
Med-5th Bldg. 7-3-1 Hongo, Bunkyo-The intervention, Tokyo 113-0033 JAPAN
TEL
03-5841-3439
Homepage URL
qinqi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
Kitamura clinic Pontianak, Indonesia
RSUD Dr.Soedarso Pontianak, Indonesia
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044485
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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