UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037479
Receipt number R000042698
Scientific Title Foot screening and foot bottom plate inserted effect for diabetes patients
Date of disclosure of the study information 2019/08/01
Last modified on 2019/07/24 18:19:58

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Basic information

Public title

Foot screening and foot bottom plate inserted effect for diabetes patients

Acronym

Foot screening and foot bottom plate inserted effect for diabetes patients

Scientific Title

Foot screening and foot bottom plate inserted effect for diabetes patients

Scientific Title:Acronym

Foot screening and foot bottom plate inserted effect for diabetes patients

Region

Japan


Condition

Condition

Diabetic foot lesions

Classification by specialty

Endocrinology and Metabolism Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

For diabetic patients, we aim to detect the deformation of the foot and the heel, the abnormality of the plantar pressure in the compensated walking at an early stage, and to detect and prevent the foot ulcer and the foot ganglia early.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The score of QOL (SF-36) before and after intervention and the deviation score from the national standard value

Key secondary outcomes

1 Proportion of the number of solos before and after intervention
2 Walking speed before and after intervention
3 Difference in the degree of pain during walking before and after intervention (VAS evaluation)
In VAS, 0 is not painful at all. The right end of a length of 10 cm is regarded as unbearable pain, and it is indicated where the current pain is, and the length is measured and scored.
4 Average plantar peak pressure before and after intervention


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Prepare a plantar plate for the failure prevention purpose that may be considered from the result of alignment evaluation of standing position and measurement of plantar pressure, or an obstacle that has already occurred, and continue it for 1 year.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Have a diagnosis of diabetes and have a neurological disorder
2) Walking is independent

Key exclusion criteria

1) I can not get consent or understanding because of cognitive decline
2) Serious foot lesion, foot deformity

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Ikuko
Middle name
Last name Itou

Organization

Shimane University School of Medicine Hospital

Division name

Rehabilitation department

Zip code

6938501

Address

Izumo, Shimane Prefecture Enya-cho, 89-1

TEL

0853202457

Email

konnitiwa.itou@gmail.com


Public contact

Name of contact person

1st name Ikuko
Middle name
Last name Itou

Organization

Shimane University School of Medicine Hospital

Division name

Rehabilitation department

Zip code

6938501

Address

Izumo, Shimane Prefecture Enya-cho, 89-1

TEL

0853202457

Homepage URL


Email

konnitiwa.itou@gmail.com


Sponsor or person

Institute

Shimane University School of Medicine Hospital Rehabilitation department

Institute

Department

Personal name



Funding Source

Organization

Shimane University School of Medicine Hospital Rehabilitation department

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ikuko Itou

Address

Izumo, Shimane Prefecture Enya-cho, 89-1

Tel

0853202457

Email

konnitiwa.itou@gmail.com


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

2019 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

3

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

Terminated

Date of protocol fixation

2015 Year 12 Month 16 Day

Date of IRB

2015 Year 10 Month 19 Day

Anticipated trial start date

2015 Year 12 Month 16 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 07 Month 24 Day

Last modified on

2019 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042698


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name