UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042091 |
|---|---|
| Receipt number | R000047812 |
| Scientific Title | Prospective intervention study aimed at establishing a circumference measurement method for lower limb lymphedema. |
| Date of disclosure of the study information | 2020/10/19 |
| Last modified on | 2020/10/12 19:54:01 |
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Basic information
Public title
A study investigating how to measure lower limb edema.
Acronym
Study of lower limb edema.
Scientific Title
Prospective intervention study aimed at establishing a circumference measurement method for lower limb lymphedema.
Scientific Title:Acronym
Study of lower limb lymphedema.
Region
| Japan |
Condition
Condition
Lower limb edema.
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The most effective circumference measurement will be clarified by comparing the volume and circumference calculated by Perometer with the volume and circumference of each of the 5-point and 10-point manual circumferential measurement for patients with lower limb edema.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The lower limb volume measured by the Perometer on the same day and at the same time is compared with the lower limb volume calculated by the 5-point method of the circumference measurement method and the lower limb volume calculated by the 10-point method, and the correlation and error are tested.
Key secondary outcomes
Compare the perimeter of the lower limbs measured by the perometer with the perimeter of the lower limbs measured by the 5-point and 10-point methods.
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
Using a perometer that measures the volume by irradiating the lower limbs with infrared rays, the circumference of the lower limbs and the volume of the lower limbs are measured in 80 cases.
Subjects rest for 15 minutes before making measurements.
Subjects are instructed to avoid strenuous exercise and alcohol consumption 24 hours before the measurement and to limit eating and drinking 1 hour before the start of the measurement.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who can take a standing posture.
Those who have obtained consent for this research by signing the consent form by the person himself / herself.
Key exclusion criteria
Patients with deep vein thrombosis
Patients with serious heart disease
Persons with serious liver disease (or persons with AST 100U/L or less)
Persons with severe renal disease (or serum creatinine 1.3mg/dl or higher)
Women who are pregnant or may become pregnant
Patients with a pacemaker
Patients with venous disease
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Sano |
Organization
Hamamatsu University School of Medicine Hospital
Division name
Second Surgery Department Group
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2111
m.sano@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yurina |
| Middle name | |
| Last name | Yokoyama |
Organization
Hamamatsu University School of Medicine Hospital
Division name
Rehabilitation department
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2747
Homepage URL
yrn.hashimoto.0619@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine Hospital rehabilitation department
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine Hospital rehabilitation department
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
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-2680
rinri@hama-med.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
| 2020 | Year | 10 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 06 | 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
| 2020 | Year | 10 | Month | 12 | Day |
Last modified on
| 2020 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047812
