UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051195 |
|---|---|
| Receipt number | R000058380 |
| Scientific Title | Implementation study of diabetic foot ulcer prevention protocol in Indonesia |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2025/04/29 19:48:43 |
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Basic information
Public title
Implementation study of diabetic foot ulcer prevention protocol in Indonesia
Acronym
Implementation study of diabetic foot ulcer prevention protocol in Indonesia
Scientific Title
Implementation study of diabetic foot ulcer prevention protocol in Indonesia
Scientific Title:Acronym
Implementation study of diabetic foot ulcer prevention protocol in Indonesia
Region
| Asia(except Japan) |
Condition
Condition
Diabetic foot ulcer
Classification by specialty
| Dermatology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of this study is to introduce a diabetic foot clinic for the prevention of diabetic foot ulcer and to determine the incidence rate in Indonesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of diabetic foot ulcers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Diabetic foot clinic for the prevention of diabetic foot ulcer
Interventions/Control_2
Education on the prevention of diabetic foot ulcers using booklets conventionally conducted at Community Health Centers
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
Patients with diabetes go to the Community Health Center Alianyang (Intervention Group) or Community Health Center Sei Durian (Control Group) and over the age of 18.
Key exclusion criteria
Patients with large lower limb amputation, cannot participate in this study for 12 months, do not speak Indonesian, medical condition not suitable for the study (judge by physician-in-charge)
Target sample size
142
Research contact person
Name of lead principal investigator
| 1st name | Suriadi |
| Middle name | |
| Last name | Suriadi |
Organization
School of Nursing Science of Muhammadiyah Pontianak
Division name
School of Nursing Science of Muhammadiyah Pontianak
Zip code
-
Address
Jl. Sungai Raya Dalam Gg. Ceria V No.10, Pontianak - Kalimantan Barat. Indonesia
TEL
+62561711837
suriadif@yahoo.com.au
Public contact
Name of contact person
| 1st name | Suriadi |
| Middle name | |
| Last name | Suriadi |
Organization
School of Nursing Science of Muhammadiyah Pontianak
Division name
School of Nursing Science of Muhammadiyah Pontianak
Zip code
-
Address
Jl. Sungai Raya Dalam Gg. Ceria V No.10, Pontianak - Kalimantan Barat. Indonesia
TEL
+62561711837
Homepage URL
suriadif@yahoo.com.au
Sponsor or person
Institute
School of Nursing Science of Muhammadiyah Pontianak
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanazawa University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Nursing Science of Muhammadiyah Pontianak
Address
Jl. Sungai Raya Dalam Gg. Ceria V No.10, Pontianak - Kalimantan Barat. Indonesia
Tel
+62561711837
suriadif@yahoo.com.au
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 | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/10.1177/15347346251337267
Number of participants that the trial has enrolled
142
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
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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 | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058380
