UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006883 |
|---|---|
| Receipt number | R000008132 |
| Scientific Title | Interface pressures derived from oversized compression stockings. |
| Date of disclosure of the study information | 2011/12/14 |
| Last modified on | 2012/06/14 16:43:46 |
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Basic information
Public title
Interface pressures derived from oversized compression stockings.
Acronym
Interface pressures derived from oversized compression stockings.
Scientific Title
Interface pressures derived from oversized compression stockings.
Scientific Title:Acronym
Interface pressures derived from oversized compression stockings.
Region
| Japan |
Condition
Condition
Chronic venous insufficiency
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate interface pressures derived from class II and III compression stockings of various sizes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interface pressures obtained by each stocking in supine and standing position.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearing compression S-size stockings.
Interventions/Control_2
Wearing compression M-size stockings.
Interventions/Control_3
Wearing compression L-size stockings.
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
Healthy male or female between 20 and 100 years, who have S,M,L size legs defined by MAXIS a.s.,Czech Republic.
Key exclusion criteria
The subeject who cannot tolerate this study physically or mentally.
The subject with ABI<0.7.
Otherwise, the physician decided that he/she should not be included in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kotaro Suehiro |
Organization
Yamaguchi University, School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
0836-22-2261
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yamaguchi University, School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
Address
TEL
0836-22-2261
Homepage URL
Sponsor or person
Institute
Yamaguchi University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University, School of Medicine
Organization
Division
Category of Funding 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
| 2011 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2001 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 13 | Day |
Last modified on
| 2012 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008132
