UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048341 |
|---|---|
| Receipt number | R000049737 |
| Scientific Title | Safety and Usability of semi-ready-made shoe orthoses designed for patients with daiabetic foot. |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2022/07/12 09:24:42 |
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Basic information
Public title
Safety and Usability of semi-ready-made shoe orthoses designed for patients with daiabetic foot.
Acronym
Safety and Usability of semi-ready-made shoe orthoses designed for patients with daiabetic foot.
Scientific Title
Safety and Usability of semi-ready-made shoe orthoses designed for patients with daiabetic foot.
Scientific Title:Acronym
Safety and Usability of semi-ready-made shoe orthoses designed for patients with daiabetic foot.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and usability of semi-ready-made last orthoses designed for the conservative treatment of callus or ulcerated feet with diabetic foot. Specifically, a shoe-shaped orthosis made of a wooden pattern that matches the length of the foot will be used continuously for 3 months to evaluate the condition of the callus or ulcer and verify its safety and usability.
Basic objectives2
Others
Basic objectives -Others
Examining the usability of shoe-type orthoses such as comfort, weight, and comfort by subjective evaluation by the subject
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pressure inside the last orthosis, callus or ulcer size
Key secondary outcomes
Subjective evaluation of usability of shoe lasts using questionnaires
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*Pressure inside of the shoe orthosis
*size of callus
*size of ulcer
Key exclusion criteria
Subjectively evaluate the usability of shoe orthoses using a questionnaire
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Fujitani |
Organization
National Center for Global Health and
Medicine
Division name
Depertment of Rehabilitation Medicine
Zip code
162-8655
Address
1-21-1,Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
jufujita@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Kikuchi |
Organization
National Center for Global Health and Medicine
Division name
Depertment of Rehabilitation Medicine
Zip code
162-8655
Address
1-21-1,Toyama, Shinjuku-ku, Tokyo, Japan
TEL
0332127081
Homepage URL
kkikuchi@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
VAN SAN-SHO, ING
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1,Toyama, Shinjuku-ku, Tokyo, Japan
Tel
0332127081
kenkyu-shinsa@hosp.ncgm.go.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
国立国際医療研究センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 12 | 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
4
Results
under analysis
Results date posted
| 2022 | Year | 07 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
DM
Participant flow
under analysis
Adverse events
none
Outcome measures
Pressure inside shoe-shaped equipment
The size of the callus or ulce
Plan to share IPD
under consideration
IPD sharing Plan description
under consideration
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049737
