UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045788 |
|---|---|
| Receipt number | R000052272 |
| Scientific Title | Effect of toothbrush cleaning on healing of intractable wounds. |
| Date of disclosure of the study information | 2021/12/28 |
| Last modified on | 2022/04/19 09:41:53 |
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Basic information
Public title
Wound healing by toothbrush cleaning
Acronym
toothbrush
Scientific Title
Effect of toothbrush cleaning on healing of intractable wounds.
Scientific Title:Acronym
toothbrush cleaning
Region
| Japan |
Condition
Condition
intractable foot ulcer
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of ulcer healing by toothbrush washing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
reduction of ulcer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
toothbrush cleaning continued for 4 weeks
Interventions/Control_2
normal treatment
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with refractory ulcers who can be cleaned with a toothbrush
Key exclusion criteria
have a tendency to bleed
have a lot of pain
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | RICA |
| Middle name | |
| Last name | TANAKA |
Organization
Juntendo University
Division name
plastic surgery
Zip code
1138431
Address
3-1-3,Hongo Bunkyo-ku, Tokyo
TEL
03-3813-3111
rtanaka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | YUKO |
| Middle name | |
| Last name | TACHIBANA |
Organization
Juntendo University Hospital
Division name
podiatry center
Zip code
113-8431
Address
3-1-3,Hongo Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
yutamai@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Lion Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
3-1-3,Hongo Bunkyo-ku, Tokyo
Tel
03-3813-3111
yutamai@juntendo.ac.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
| 2021 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 18 | Day |
Last modified on
| 2022 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052272
