UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009148 |
|---|---|
| Receipt number | R000010725 |
| Scientific Title | The effect of elastic stocking on the leg lymph function assessed by indocyanine-green-fluorescence lymph vessel imaging |
| Date of disclosure of the study information | 2012/10/22 |
| Last modified on | 2016/04/20 17:15:40 |
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Basic information
Public title
The effect of elastic stocking on the leg lymph function assessed by indocyanine-green-fluorescence lymph vessel imaging
Acronym
Assessment of the effect of elastic stocking on lymph pumping pressure and general health performance
Scientific Title
The effect of elastic stocking on the leg lymph function assessed by indocyanine-green-fluorescence lymph vessel imaging
Scientific Title:Acronym
Assessment of the effect of elastic stocking on lymph pumping pressure and general health performance
Region
| Japan |
Condition
Condition
Perturbance of lymph perfusion
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the effect of elastic stocking on lymph pumping pressure and general health performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
indocyanine green fluorescence lymphography, lymphatic pumping pressure
SF-36 interview
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Recrute healthy volunteers with leg lymph pumping less than 20 mmHg lymph ejection pressure fell to 20 or less mmHg. Test the effect of elastic stocking on the improvement of leg lymph pumping and general health condition after 4 months.
Interventions/Control_2
Control group with non elastic stocking
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
healthy volunteers whom lymph ejection pressure fell to 20 or less mmHg
Key exclusion criteria
chronic venous insufficiency (CVI) such as varicose vein and deep vein thrombosis,
People with past medical history of leg injury, patients with secondary lymphedema (pelvic surgery such as uterus, prostate, and rectal surgery)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Unno |
Organization
Hamamatsu University School of Medicine
Division name
Vascular surgery
Zip code
Address
Hamamatsu University School of Medicine,1-20-1Handayama,Higashi-ku,Hamamatsu-shi, Shizuoka, 431-3125, Japan
TEL
053-435-2273
r.sugisawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryota Sugisawa |
Organization
Hamamatsu University School of Medicine,
Division name
Vascular surgery
Zip code
Address
Hamamatsu University School of Medicine,1-20-1Handayama,Higashi-ku,Hamamatsu-shi, Shizuoka, 431-3125
TEL
053-435-2273
Homepage URL
r.sugisawa@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Toray Opelontex Co., Ltd.
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
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
| 2012 | Year | 10 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 19 | Day |
Last modified on
| 2016 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010725
