UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neuropathy assessment indicators for patients with diabetes: investigation of footcare intervention programs incorporating the DPN check by risk of foot ulcer incidence
Title of the study (Brief title)	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	Masuko Sumikawa
Organization	Sapporo Medical University
Division name	Department of Nursing School of Health Science
Address	Minami 1 Nishi 17 Chuo-Ku,Sapporo
TEL	011-611-2111
Email	masuko0811@sapmed.ac.jp

Public contact
Name of contact person	Masuko Sumikawa
Organization	Sapporo Medical University
Division name	Department of Nursing School of Health Science
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 21 Day
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

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Publication of results	Unpublished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