UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030587
Receipt number 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 11:19:17

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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 or person

Institute

Sapporo medical university hospital

Institute

Department

Personal name



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

Value
https://center6.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