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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004070
Receipt No. R000004900
Scientific Title Efficacy of preventive foot care for diabetic high-risk foot patients at outpatients' clinic
Date of disclosure of the study information 2010/08/20
Last modified on 2010/08/19

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Basic information
Public title Efficacy of preventive foot care for diabetic high-risk foot patients at outpatients' clinic
Acronym NHO-Diabetic Foot 1 study
Scientific Title Efficacy of preventive foot care for diabetic high-risk foot patients at outpatients' clinic
Scientific Title:Acronym NHO-Diabetic Foot 1 study
Region
Japan

Condition
Condition diabetic patients
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We conduct this clinical study in order to examine the efficacy of preventive foot care for diabetic high-risk foot patients at outpatients' clinic, after standardization of the practioner's skill.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diabetic foot ulcer incidence rate, foot amputation rate, major amputation rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Patients record their foot conditions at home, and recieve skin care by practioners at outpatients' clinic, and education
Interventions/Control_2 Control patients don't usually recieve regular intensive foot care.
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 Diabetic patients who have at least one condition described below
1) Past history of foot ulcer and/or amputation
2) Peripheral arterial disease (ABI<0.7)
3) Diabetic neuropathy (insensitive to 5.07 monofilament)
Key exclusion criteria Diabetic patients who have past history of foot ulcer and/or amputation due to trauma etc. without diabetic neuropathy and/or PAD.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Kono
Organization Nationa Hospital Organization, Kyoto Medical Center
Division name Diabetes center
Zip code
Address 1-1 Fukakusaukaihatacho, Fushimiku, Kyoto, Japan
TEL 075-641-9161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigeo Kono
Organization Nationa Hospital Organization, Kyoto Medical Center
Division name Diabetes Center
Zip code
Address
TEL 075-641-9161
Homepage URL
Email

Sponsor
Institute National Hospital Organization
Kyoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 20 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 Preinitiation
Date of protocol fixation
2010 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 19 Day
Last modified on
2010 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004900

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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