UMIN-CTR Clinical Trial

Basic information
Public title	Foot screening and foot bottom plate inserted effect for diabetes patients
Acronym	Foot screening and foot bottom plate inserted effect for diabetes patients
Scientific Title	Foot screening and foot bottom plate inserted effect for diabetes patients
Scientific Title:Acronym	Foot screening and foot bottom plate inserted effect for diabetes patients
Region	Japan

Condition
Condition	Diabetic foot lesions
Classification by specialty	Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For diabetic patients, we aim to detect the deformation of the foot and the heel, the abnormality of the plantar pressure in the compensated walking at an early stage, and to detect and prevent the foot ulcer and the foot ganglia early.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The score of QOL (SF-36) before and after intervention and the deviation score from the national standard value
Key secondary outcomes	1 Proportion of the number of solos before and after intervention 2 Walking speed before and after intervention 3 Difference in the degree of pain during walking before and after intervention (VAS evaluation) In VAS, 0 is not painful at all. The right end of a length of 10 cm is regarded as unbearable pain, and it is indicated where the current pain is, and the length is measured and scored. 4 Average plantar peak pressure before and after intervention

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Prepare a plantar plate for the failure prevention purpose that may be considered from the result of alignment evaluation of standing position and measurement of plantar pressure, or an obstacle that has already occurred, and continue it for 1 year.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Have a diagnosis of diabetes and have a neurological disorder 2) Walking is independent
Key exclusion criteria	1) I can not get consent or understanding because of cognitive decline 2) Serious foot lesion, foot deformity
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Ikuko Middle name Last name Itou
Organization	Shimane University School of Medicine Hospital
Division name	Rehabilitation department
Zip code	6938501
Address	Izumo, Shimane Prefecture Enya-cho, 89-1
TEL	0853202457
Email	konnitiwa.itou@gmail.com

Public contact
Name of contact person	1st name Ikuko Middle name Last name Itou
Organization	Shimane University School of Medicine Hospital
Division name	Rehabilitation department
Zip code	6938501
Address	Izumo, Shimane Prefecture Enya-cho, 89-1
TEL	0853202457
Homepage URL
Email	konnitiwa.itou@gmail.com

Sponsor
Institute	Shimane University School of Medicine Hospital Rehabilitation department
Institute
Department

Funding Source
Organization	Shimane University School of Medicine Hospital Rehabilitation department
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ikuko Itou
Address	Izumo, Shimane Prefecture Enya-cho, 89-1
Tel	0853202457
Email	konnitiwa.itou@gmail.com

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 08 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	3
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	Terminated
Date of protocol fixation	2015 Year 12 Month 16 Day
Date of IRB	2015 Year 10 Month 19 Day
Anticipated trial start date	2015 Year 12 Month 16 Day
Last follow-up date	2022 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 24 Day
Last modified on	2019 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042698