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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030587
Receipt No. R000034818
Scientific Title Neuropathy assessment indicators for patients with diabetes: investigation of footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence
Date of disclosure of the study information 2018/12/21
Last modified on 2017/12/27

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Basic information
Public title Neuropathy assessment indicators for patients with diabetes: investigation of footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence
Acronym Neuropathy assessment indicators for patients with diabetes: investigation of footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence
Scientific Title Neuropathy assessment indicators for patients with diabetes: investigation of footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence
Scientific Title:Acronym Neuropathy assessment indicators for patients with diabetes: investigation of footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence
Region
Japan

Condition
Condition diabetes
Classification by specialty
Endocrinology and Metabolism Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is designed to investigate footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence for patients with daiabtes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the presence or absence of diabetic complications, foot lesions, subjective symptoms
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom Maneuver
Interventions/Control_1 To assess severity of foot ulcer based on the risk classification chart incorporating the DPNCheck-based neuropathy assessment in patients with diabetes, implement periodic follow-up footcare intervention at a frequency based on the risk, and verify efficacy of the foot care intervention program
The time for each intervention is 30-60min
care.
The contents of intervention; the checking of foot conditons and footcare behaiviors,nail clipping,and callus treatment,supports of selfcare.
risk0(normal);every a year
risk1(mild) ;every 6 months
risk2(moderate);every 3-4months
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
80 years-old >
Gender Male and Female
Key inclusion criteria Individuals who had a clear understanding, participated voluntarily, and consented to the study in writing after receiving sufficient explanation pertaining to participation in the study
Key exclusion criteria 1.Those who were judged by the physician or nurse to be physically and mentally unsuitable for participating in the study
2.Those who were judged by the physician or nurse to have difficulty in self-expression and undertaking foot care (cleaning, foot observation, trauma prevention, and topical application) on their own, because of psychiatric disorders or dementia
3.Those who expressed inability to perform long-term activities, such as cleaning their own foot because of upper limb or finger disorders, or were judged by the physician or nurse to have such inabilities (excluding those who could not perform the tasks temporarily because of injury)
4.Those who expressed difficulty in reading the informed consent document required for participating in this study, because of vision disorders
5.Others who were judged by the physician or the nurse to be unsuitable as participants
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masuko Sumikawa
Organization Sapporo Medical University
Division name Department of Nursing School of Health Science
Zip code
Address Minami 1 Nishi 17 Chuo-Ku,Sapporo
TEL 011-611-2111
Email masuko0811@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masuko Sumikawa
Organization Sapporo Medical University
Division name Department of Nursing School of Health Science
Zip code
Address Minami 1 Nishi 17 Chuo-Ku,Sapporo
TEL 011-611-2111
Homepage URL
Email masuko0811@sapmed.ac.jp

Sponsor
Institute Sapporo medical university hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 12 Month 21 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 Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 21 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
2017 Year 12 Month 27 Day
Last modified on
2017 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034818

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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