UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036366 |
|---|---|
| Receipt number | R000041347 |
| Scientific Title | Risk stratification of diabetic foot ulceration based on foot pressure patterns while walking using machine learning |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2022/07/28 14:37:05 |
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Basic information
Public title
Risk stratification of diabetic foot ulceration based on foot pressure patterns while walking using machine learning
Acronym
ML-based risk stratification of DFU by plantar pressure pattern classification
Scientific Title
Risk stratification of diabetic foot ulceration based on foot pressure patterns while walking using machine learning
Scientific Title:Acronym
ML-based risk stratification of DFU by plantar pressure pattern classification
Region
| Japan |
Condition
Condition
Type 2 diabetes
Peripheral arterial disease
Healthy elderly people
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Vascular surgery |
| Orthopedics | Plastic surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
ML-based prediction of DFU by plantar pressure distribution for diabetic patients.
Basic objectives2
Others
Basic objectives -Others
Verification of the validity of plantar pressure pattern classification in the risk of DFU.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
DFU formation.(Classification of DFU formation risk)
Key secondary outcomes
Validity of evaluation method of DFU formation risk.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Ambulatory diabetic patients or patients with minor amputation history due to insufficient blood flow.
2.Patients consent to participate in this study.
Key exclusion criteria
1.Patients have a pain in knee or hip while walking.
2.Non-ambulatory patients without orthosis due to cerebrovascular disease.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Hayashi |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
476-8588
Address
2-172, Fukinodai, Tokai City, Aichi Prefecture, Japan
TEL
052-601-6000
hisaehayashi@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisae |
| Middle name | |
| Last name | Hayashi |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
476-8588
Address
2-172, Fukinodai, Tokai City, Aichi Prefecture, Japan
TEL
052-601-6000
Homepage URL
hisaehayashi@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
The Japan Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya University Graduate School
Kobe University School of Medicine
Gifu University of Health Sciences Junior College
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seijoh University Ethics Committee
Address
2-172, Fukinodai, Tokai City, Aichi Prefecture, Japan
Tel
052-601-6000
fujita@seijoh-u.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
星城大学(愛知県)、増子記念病院（愛知県）、名古屋共立病院（愛知県）、松波総合病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | 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
100
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
| 2018 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 04 | Month | 01 | Day |
Last modified on
| 2022 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041347
