UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033562
Receipt number R000038275
Scientific Title Investigation of the effects of foot care on self-care and related factors in diabetic patients.
Date of disclosure of the study information 2018/08/01
Last modified on 2022/10/23 08:54:32

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Basic information

Public title

Investigation of the effects of foot care on self-care and related factors in diabetic patients.

Acronym

Investigation of the effects of foot care on self-care and related factors in diabetic patients.

Scientific Title

Investigation of the effects of foot care on self-care and related factors in diabetic patients.

Scientific Title:Acronym

Investigation of the effects of foot care on self-care and related factors in diabetic patients.

Region

Japan


Condition

Condition

diabetes

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this research is to investigate the effects of foot care on self-care and related factors in diabetic patients in order to enhance support and guidance for them.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

After providing foot care to diabetic patients, a questionnaire is conducted to investigate in their self-care.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

The intervention includes; 1)offering a footbath and trimming nails, 2) checking vibration perception and pressure sensation in the foot, and 3) checking whether each patient's goal of foot care is achieved. The intervention is 30 minutes long and is offered once a month for 6 months.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who are judged to require foot care by their doctors.

Key exclusion criteria

Patients who cannot answer the questionnaire.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Ayami
Middle name
Last name Hayashi

Organization

Fukushima Medical University School of Nursing

Division name

Department of Fundamental Nursing

Zip code

9601295

Address

1 Hikarigaoka, Fukushima-shi, Fukushima ,Japan

TEL

024-547-1865

Email

yami@fmu.ac.jp


Public contact

Name of contact person

1st name Ayami
Middle name
Last name Hayashi

Organization

Fukushima Medical University School of Nursing

Division name

Department of Fundamental Nursing

Zip code

9601295

Address

1 Hikarigaoka, Fukushima-shi, Fukushima ,Japan

TEL

024-547-1865

Homepage URL


Email

yami@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

Fukushima Medical University

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

Fukushima Medical University School of Nursing

Address

1 Hikarigaoka, Fukushima-shi, Fukushima ,Japan

Tel

024-547-1865

Email

yami@fmu.ac.jp


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 08 Month 01 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

Delay expected

Results Delay Reason

Due to the impact of COVID-19, the number of patients could not be gathered.

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

2018 Year 03 Month 20 Day

Date of IRB

2018 Year 03 Month 08 Day

Anticipated trial start date

2018 Year 03 Month 20 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 07 Month 30 Day

Last modified on

2022 Year 10 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038275


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name