UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027188
Receipt number R000031156
Scientific Title Retrospective study for relation between plantar wound and sensory disturbance and plantar pressure in patients with Hansen's disease
Date of disclosure of the study information 2017/04/29
Last modified on 2019/05/24 09:54:05

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Basic information

Public title

Retrospective study for relation between plantar wound and sensory disturbance and plantar pressure in patients with Hansen's disease

Acronym

Retrospective study for relation between plantar wound and sensory disturbance and plantar pressure in patients with Hansen's disease

Scientific Title

Retrospective study for relation between plantar wound and sensory disturbance and plantar pressure in patients with Hansen's disease

Scientific Title:Acronym

Retrospective study for relation between plantar wound and sensory disturbance and plantar pressure in patients with Hansen's disease

Region

Japan


Condition

Condition

Hansen disease

Classification by specialty

Neurology Dermatology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To Improve prevention method for plantar ulcer of Hansen's disease

Basic objectives2

Others

Basic objectives -Others

Retrospective cross-sectional study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Plantar sensory dysfunction and plantar pressure, plantar wound

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

120 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who are tested for both of plantar sensory function and plantar pressure from
201402016 by clinical demands

Key exclusion criteria

none

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Syoichi
Middle name
Last name Tashiro

Organization

Tama Zensho-en National Sanatorium

Division name

Dept Rehabilitation

Zip code

181-0004

Address

4-1-1, Aoba-cho, Higashi-Murayama city, Tokyo

TEL

042-395-1101

Email

s-tashiro@umin.net


Public contact

Name of contact person

1st name Syoichi
Middle name
Last name Tashiro

Organization

Tama Zensho-en National Sanatorium

Division name

Dept Rehabilitation

Zip code

181-0004

Address

4-1-1, Aoba-cho, Higashi-Murayama city, Tokyo

TEL

042-395-1101

Homepage URL


Email

s-tashiro@umin.net


Sponsor or person

Institute

National Tama Zensho-en Sanatorium

Institute

Department

Personal name



Funding Source

Organization

none

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

Ethical committee of Tama Zensho-en National Sanatorium

Address

4-1-1, Aoba-cho, Higashi-Murayama city, Tokyo

Tel

042-395-1101

Email

rinri@zenshoen.net


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

2017 Year 04 Month 29 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

10

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

Main results already published

Date of protocol fixation

2017 Year 04 Month 20 Day

Date of IRB

2017 Year 04 Month 20 Day

Anticipated trial start date

2017 Year 04 Month 20 Day

Last follow-up date

2019 Year 01 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Subjects have decided


Management information

Registered date

2017 Year 04 Month 29 Day

Last modified on

2019 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031156


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name