UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005671 |
|---|---|
| Receipt number | R000006631 |
| Scientific Title | Analysis of foot pressure and treatment using the insole device for the patients with ingrown nail |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2011/05/30 15:31:51 |
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Basic information
Public title
Analysis of foot pressure and treatment using the insole device for the patients with ingrown nail
Acronym
Analysis of foot pressure and treatment using the insole device for the patients with ingrown nail
Scientific Title
Analysis of foot pressure and treatment using the insole device for the patients with ingrown nail
Scientific Title:Acronym
Analysis of foot pressure and treatment using the insole device for the patients with ingrown nail
Region
| Japan |
Condition
Condition
ingrown nail
Classification by specialty
| Dermatology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although ingrown nail is a common disease, its definite etiology remains unclear. Plausible mechanisms include physical stress due to ill-fitting shoes and inappropriate nail cutting. On the other hand, Clinicians recognize high incidence of ingrown nail among bedridden patients free from weight bearing. Mechanical stress of walking and load likely affects the nail morph and the pathophysiology of nail deformity. This study aims to evaluate the influence of mechanical stress on the nail morph by analysis of plantar pressure dynamics. The patients who have plantar load imbalance will undergo the insole treatment to improve the walking patterns.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Curve index (defined as nail height / nail width)
Analysis of plantar pressure dynamics
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients treated with the insole
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 with ingrown nail
Key exclusion criteria
bedridden patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Shiokawa |
Organization
Saitama medical center
Division name
Plastic and Reconstructive Surgery,
Zip code
Address
1981 Kamoda, Kawagoe-shi, SAITAMA
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Saitama medical university hospital
Division name
Plastic and Reconstructive Surgery
Zip code
Address
TEL
Homepage URL
sasasa116sasasa@hotmail.com
Sponsor or person
Institute
Saitama medical center
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 06 | Month | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 30 | Day |
Last modified on
| 2011 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006631
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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