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

Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name