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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027819
Receipt No. R000031873
Scientific Title Verification of effectiveness of self-foot -care educational program on prevention against diabetic foot disease.
Date of disclosure of the study information 2017/06/19
Last modified on 2017/06/19

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Basic information
Public title Verification of effectiveness of self-foot -care educational program on prevention against diabetic foot disease.
Acronym Self-foot-care educational program against diabetic foot disease.
Scientific Title Verification of effectiveness of self-foot -care educational program on prevention against diabetic foot disease.
Scientific Title:Acronym 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
1st name
Middle name
Last name Kumi Suzuki
Organization Osaka Medical College
Division name Faculty of Nursing
Zip code
Address 7-6 Nishimachi, Hacho,Takatsuki-Shi,Osaka
TEL 072-684-7281
Email yokota29@iris.eonet.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kayo Yokota
Organization Osaka Medical College
Division name Faculty of Nursing
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2017 Year 06 Month 19 Day
Date of IRB
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

Other
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

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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