UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047239 |
|---|---|
| Receipt number | R000053878 |
| Scientific Title | Examination of long-term recurrence rate of surgical offloading at the same time as ulcer cloased operation. |
| Date of disclosure of the study information | 2022/03/21 |
| Last modified on | 2023/09/21 18:48:16 |
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Basic information
Public title
Examination of long-term recurrence rate of surgical offloading at the same time as ulcer cloased operation.
Acronym
Examination of long-term recurrence rate of surgical offloading at the same time as ulcer cloased operation.
Scientific Title
Examination of long-term recurrence rate of surgical offloading at the same time as ulcer cloased operation.
Scientific Title:Acronym
Examination of long-term recurrence rate of surgical offloading at the same time as ulcer cloased operation.
Region
| Japan |
Condition
Condition
hard-to-heal foot ulcer
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of long-term recurrence rate of surgical off loading at the same time as ulcer closed operation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The examination of recurrence rate of foot ulcer.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
When closed operation, correct the foot deformity that may be related to the recurrence of the ulcer.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient have consented to this treatment.
Key exclusion criteria
The patient have not consented to this treatment.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Terabe |
Organization
Kasube Chuo General Hospital
Division name
Limb salvage center
Zip code
3440063
Address
midori5-9-4, Kasukabe, Saitama, Japan
TEL
0487361221
k.sk.tera@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Terabe |
Organization
Kasukabe Chuo General Hospital
Division name
Limb salvage center
Zip code
3440063
Address
midori5-9-4, Kasukabe, Saitama, Japan
TEL
0487361221
Homepage URL
k.sk.tera@gmail.com
Sponsor or person
Institute
Kasukabe Chuo General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kasukabe Chuo General Hospital
Address
midori5-9-4, Kasukabe, Saitama, Japan
Tel
04873761221
k.sk.tera@gmail.com
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
| 2022 | Year | 03 | Month | 21 | 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
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 03 | Month | 21 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053878
