UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047076 |
|---|---|
| Receipt number | R000048079 |
| Scientific Title | Study of shoe components for diabetic foot risk and foot ulcerin patients. |
| Date of disclosure of the study information | 2022/03/04 |
| Last modified on | 2023/03/14 10:53:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of shoe components for diabetic foot
risk and foot ulcerin patients.
Acronym
Study of shoe components for diabetic foot
risk and foot ulcerin patients.
Scientific Title
Study of shoe components for diabetic foot
risk and foot ulcerin patients.
Scientific Title:Acronym
Study of shoe components for diabetic foot
risk and foot ulcerin patients.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the pressure conditions inside the shoe and determine the height of the toe box of the last orthosis suitable for preventing ulceration.
Basic objectives2
Others
Basic objectives -Others
Evaluate the support (rigidity) of shoe lasts in diabetic foot lesions. Specifically, it is examined whether the supportability of the foot is changed by changing the length of the lunar shin, which affects the rigidity of the heel shoe.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pressure inside the shoe
Key secondary outcomes
Calcaneus valgus angle / medial longitudinal arch height
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
Key inclusion criteria
* Men with a history of diabetes
*Healthy adult male with no history of diabetes
*Deformation of the toes (hammer toe, claw toe) is seen
*No ulcers on the soles and toes
Key exclusion criteria
*hose who have new skin problems on their feet
*Persons with infiltration such as exudate from ulcer
*Those who the principal investigator has determined to be inappropriate for inclusion in the research
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Fujitani |
Organization
Nationnal Center Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
162-8655
Address
1-21-1, toyama, shinjuku-ku, Tokyo
TEL
0332027181
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
department of rehabilitation medicine
Zip code
162-8655
Address
1-21-1, toyama, shinjuku-ku, Tokyo
TEL
0332027181
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,INC
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
Tel
0332027181
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 | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
Results
Differences in the calcaneal valgus angle and the height of the medial longitudinal arch due to the difference in counter length were not observed. As for the pressure, it was observed that the pressure on the fingertips could be kept low by increasing the toe box.
Results date posted
| 2023 | Year | 03 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy adult, DM
Participant flow
After obtaining consent to participate in the research, the subjects put on four types of shoes prepared for this research, and the pressure inside the shoes is measured. Next, an X-ray is taken while the weight is in the standing position.
Adverse events
None
Outcome measures
*Pressure inside the shoe
*Valgus angle of the calcaneus
*Height of the medial longitudinal arch
Plan to share IPD
under consideration
IPD sharing Plan description
under consideration
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
cross-sectional study
Management information
Registered date
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048079
