UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015782 |
|---|---|
| Receipt number | R000018367 |
| Scientific Title | Study on the relation between subcutaneous tissue bioimpedance and ultrasonography in various leg edema. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2016/01/29 11:16:27 |
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Basic information
Public title
Study on the relation between subcutaneous tissue bioimpedance and ultrasonography in various leg edema.
Acronym
Correlation between leg bioimpedance and subcutaneous ultrasonography findings.
Scientific Title
Study on the relation between subcutaneous tissue bioimpedance and ultrasonography in various leg edema.
Scientific Title:Acronym
Correlation between leg bioimpedance and subcutaneous ultrasonography findings.
Region
| Japan |
Condition
Condition
Lymphedema
Chronic venous insufficiency
Classification by specialty
| Vascular surgery | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the correlation beween bioimpedance and subcutaneous ultrasonography findings in legs with edema.
Basic objectives2
Others
Basic objectives -Others
Elucidating the correlation beween bioimpedance and subcutaneous echogenicity in legs with various edema will help differentiating them.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation beween bioimpedance and subcutaneous ultrasonography findings in legs with lymphedema and venous edema.
Key secondary outcomes
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 and Female
Key inclusion criteria
All the patients with lymphedema and venous edema who will visit Edema Clinic of Yamaguchi University Hospital between January, 2015 and March, 2016.
Healhty volunteers (public advertisement).
Key exclusion criteria
The subject who cannot participate in the study due to physical or mental problem.
Target sample size
150
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
Zip code
Address
1-1-1 Minamikogushi,Ube, Yamaguchi, Japan 755-8505
TEL
0836-22-2261
kimikazu@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
Zip code
Address
1-1-1 Minamikogushi,Ube, Yamaguchi, Japan 755-8505
TEL
0836-22-2261
Homepage URL
ksuehiro@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine, Department of Surgery and Clinical Science
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine, Department of Surgery and Clinical Science
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
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
| 2014 | Year | 12 | Month | 01 | 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
We tried to test the correlation between the severity of subcutaneous echo-free space (SEFS) observed by ultrasonography and the ratio of intracellular fluid resistance to extracellular fluid resistance (Ri/Re), a surrogate parameter of fluid status assessed by bioelectrical impedance spectroscopy (BIS), in the legs with edema. Seventy legs with venous edema (VE) and 68 legs with lymphedema (LE) were studied. In the lower calf, SEFS grade showed good linear correlation with Ri/Re of the whole leg regardless of type of edema (Lower medial calf, VE: SEFS 0; 3.2+/-1.4, 1; 4.0+/-2.2, 2; 4.9+/-4.0, LE: SEFS 0; 3.2+/-0.8, 1; 3.8+/-1.7, 2; 5.3+/-3.4) . However, such correlation was not obtained in the other parts of the leg. Thus we found that severity of SEFS in the lower calf well represents the fluid status of the whole leg.
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
| 2014 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 01 | Month | 26 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 26 | Day |
Other
Other related information
No data
Management information
Registered date
| 2014 | Year | 11 | Month | 28 | Day |
Last modified on
| 2016 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018367
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