UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037207 |
|---|---|
| Receipt number | R000042418 |
| Scientific Title | Examination of callus prevention using appropriate footwear in patient with diabetic neuropathy: a randomised controlled trial |
| Date of disclosure of the study information | 2019/06/28 |
| Last modified on | 2023/01/04 11:20:21 |
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Basic information
Public title
Examination of callus prevention using appropriate footwear in patient with diabetic neuropathy
Acronym
Examination of callus prevention
Scientific Title
Examination of callus prevention using appropriate footwear in patient with diabetic neuropathy: a randomised controlled trial
Scientific Title:Acronym
Examination of callus prevention
Region
| Japan |
Condition
Condition
diabetic neuropathy
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the prevent callus formation using appropriate footwear for people with diabetic neuropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
callus formation
Key secondary outcomes
callus formation degree
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
wear appropriate footwear for one month/Interventions
Interventions/Control_2
wear own footwear/control
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
patient with diabetic nueropathy who had callus formation on first, second and fifth metatasal head
Key exclusion criteria
cannot walk without aid
a more proximal lower limb of metatasarsophalangeal joint amputation
patients who had current ulcer formation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Amemiya |
Organization
Chiba University
Division name
Graduate school of nursing
Zip code
2608672
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba
TEL
0432262402
amemiya-a@chiba-u.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Amemiya |
Organization
Chiba University
Division name
Graduate school of nursing
Zip code
2608672
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba
TEL
0432262402
Homepage URL
amemiya-a@chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate school of nursing
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ethical committee of the Graduate school of nursing, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba
Tel
0432267171
kango-rinri@chiba-u.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
| 2019 | Year | 06 | Month | 28 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | 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 | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042418
