UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of effectiveness of self-foot -care educational program on prevention against diabetic foot disease.
Title of the study (Brief title)	Self-foot-care educational program against diabetic foot disease.
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to verify the effectiveness of self-foot-care educational program on prevention against diabetic foot disease in the patients with type II diabetes mellitus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The degree of self-reliability on efficacy of self-foot-care program
Key secondary outcomes	Evaluation of monitoring ability Evaluation of self-care potency

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Intervention period 6 months Intervention 4 times
Interventions/Control_2	Intervention period 6 months Intervention 1 times
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	More than five years after making diagnosis of type II diabetes mellitus
Key exclusion criteria	1) Without Severe complications 2) Without cognitive disorder and psychotic disease 3) With being unable to read and/or write due to diabetic retinopathy
Target sample size	60

Research contact person
Name of lead principal investigator	Kumi Suzuki
Organization	Osaka Medical College
Division name	Faculty of Nursing
Address	7-6 Nishimachi, Hacho,Takatsuki-Shi,Osaka
TEL	072-684-7281
Email	yokota29@iris.eonet.ne.jp

Public contact
Name of contact person	Kayo Yokota
Organization	Osaka Medical College
Division name	Faculty of Nursing
Address	7-6 Nishimachi, Hacho,Takatsuki-Shi,Osaka
TEL	072-684-7281
Homepage URL
Email	yokota29@iris.eonet.ne.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

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	阪南市民病院（大阪府）/Hannan Municipal Hospital(Osaka)

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 19 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 06 Month 19 Day
Anticipated trial start date	2017 Year 06 Month 19 Day
Last follow-up date	2017 Year 08 Month 30 Day
Date of closure to data entry	2017 Year 10 Month 30 Day
Date trial data considered complete	2017 Year 10 Month 30 Day
Date analysis concluded	2017 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 19 Day
Last modified on	2017 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031873