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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036366
Receipt No. 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 2020/03/18

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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
Email 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
Email hisaehayashi@seijoh-u.ac.jp

Sponsor
Institute Seijoh University
Institute
Department

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
Email kishi-t@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
2020 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041347

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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