UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032921
Receipt number R000037532
Scientific Title An evaluation of pressure ulcer using fingerstall-type tissue oximetry
Date of disclosure of the study information 2018/07/01
Last modified on 2020/03/11 09:31:18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

An evaluation of pressure ulcer using fingerstall-type tissue oximetry

Acronym

Evaluation of pressure ulcer using fingerstall-type tissue oximetry

Scientific Title

An evaluation of pressure ulcer using fingerstall-type tissue oximetry

Scientific Title:Acronym

Evaluation of pressure ulcer using fingerstall-type tissue oximetry

Region

Japan


Condition

Condition

Pressure ulcer

Classification by specialty

Plastic surgery Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To get regional tissue oxygen saturation and total hemoglobin index in the pressure ulcer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Regional tissue oxygen saturation and total hemoglobin index in the pressure ulcer

Key secondary outcomes

The relationship between the regional tissue oxygen saturation and total hemoglobin index and healing process in the pressure ulcer


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Assessment of regional saturation of oxygen and total hemoglobin index in the pressure ulcer by the finger-mounted near-infrared spectroscopy

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with pressure ulcer

Key exclusion criteria

Unsuited patients for investigation such as severe infection and shock

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hidekazu
Middle name
Last name Fukamizu

Organization

Hamamatsu University School of Medicine

Division name

Plastic and Reconstructive Surgery

Zip code

4313192

Address

1-20-1 Handayama higashi-ku Hamamatsu, Japan

TEL

053-435-2155

Email

fukamizu@hama-med.ac.jp


Public contact

Name of contact person

1st name Hidekazu
Middle name
Last name Fukamizu

Organization

Hamamatsu University School of Medicine

Division name

Plastic and Reconstructive Surgery

Zip code

4313192

Address

1-20-1 Handayama higashi-ku Hamamatsu, Japan

TEL

053-435-2155

Homepage URL


Email

fukamizu@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu University School of Medicine

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

Hamamatsu University School of Medicine

Address

1-20-1 Handayama higashi-ku Hamamatsu, Japan

Tel

053-435-2155

Email

fukamizu@hama-med.acjp


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

2018 Year 07 Month 01 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

Completed

Date of protocol fixation

2018 Year 06 Month 01 Day

Date of IRB

2017 Year 10 Month 06 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 06 Month 08 Day

Last modified on

2020 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037532


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name