UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028073 |
|---|---|
| Receipt number | R000032141 |
| Scientific Title | Study on the extracellular fluid status in the legs with varicose veins of various severity. |
| Date of disclosure of the study information | 2017/07/04 |
| Last modified on | 2020/07/06 11:04:36 |
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Basic information
Public title
Study on the extracellular fluid status in the legs with varicose veins of various severity.
Acronym
Extracellular fluid status in legs with varicose vein.
Scientific Title
Study on the extracellular fluid status in the legs with varicose veins of various severity.
Scientific Title:Acronym
Extracellular fluid status in legs with varicose vein.
Region
| Japan |
Condition
Condition
Venous disease
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide the objective measure in the assessment of excess extracellular fluid accumulation in legs with varicose veins.
Basic objectives2
Others
Basic objectives -Others
Same as above.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bioimpedance in each clinical class of CEAP(Clinical, Anatomical, Etiological, Pathophysiological) classification.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Bioelectorical impedance analysis.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All the patients who visit Yamaguchi University Hospital because of varicose vein in the leg.
Key exclusion criteria
Those whom we consider inappropriate because of physical and/or mental problems.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimikazu Hamano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science, Division of Vascular Surgery
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2261
surg-1@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kotaro Suehiro |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science, Division of Vascular Surgery
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2261
Homepage URL
ksuehiro@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Clinical Science, Division of Vascular Surgery
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2017 | Year | 07 | Month | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 07 | Month | 04 | Day |
Last modified on
| 2020 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032141
