UMIN-CTR Clinical Trial

Public title

Evaluation of tissue blood flow for limb ischemia by finger-mounted tissue oximetry

Acronym

Evaluation of tissue blood flow for limb ischemia by finger-mounted tissue oximetry

Scientific Title

Evaluation of tissue blood flow for limb ischemia by finger-mounted tissue oximetry

Scientific Title:Acronym

Evaluation of tissue blood flow for limb ischemia by finger-mounted tissue oximetry

Region

Japan

Condition

Peripheral Arterial Disease

Classification by specialty

Vascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Conventionally, a non-invasive blood flow evaluation method of limb arterial disease such as obstructive arteriosclerosis and Buerger disease is used as a gold standard for ankle-ankle artery pressure ratio (ABI), and in recent years it has been reported that skin perfusion pressure (TcPO 2), percutaneous oxygen partial pressure (SPP) have also been clinically applied.However, these tests were time consuming and painful in some cases. The examination finger wearable oximeter is a device which is already on the market as an apparatus for evaluating the cerebral blood flow (brain tissue oxygen saturation) of fetus and newborn in a simple and short time on the principle of near infrared spectroscopy, It is said that blood flow can be measured anywhere as long as 5 mm from the body surface of the body. We will evaluate the blood flow of the ischemic limb using this apparatus and examine the correlation with the conventional method ABI and the superiority compared with TcPO 2 and SPP.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Comparison of measured value of rSO2 measured with a diagnostic finger wearing oximeter in the lower extremity with the conventional method (below)
Ankle-brachial artery pressure index (ABI)
Toe-brachial artery pressure index (TBI)
Percutaneous oxygen partial pressure (TcPO 2)

Key secondary outcomes

The average value of rSO 2 and T-HbI of healthy subjects and ischemic limb patients
Repeatability of repeated measurements of rSO 2, T-HbI

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

finger-mouted tissue oximetry, transcutaneous oxygen tension, skin perfusion pressure, ankle-brachial pressure index

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)healthy adult volunteers
2)patients with arteriosclerosis obliterans

Key exclusion criteria

1)Pregnant, possibly pregnant women
2)Patients who are assessed as not eligible for the study by the investigator
3)patients who do not agree

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Naoki Unno

Organization

Hamamatsu University School of Medicine

Division name

Division of Vascular Surgery, Second Department of Surgery

Zip code

Address

1-20-1 Handayama, Higashi-Ku, Hamamatsu, Shizuoka

TEL

053-435-2279

Email

unno@hama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Kazunori Inuzuka

Organization

Hamamatsu University School of Medicine

Division name

Division of Vascular Surgery, Second Department of Surgery

Zip code

Address

1-20-1 Handayama, Higashi-Ku, Hamamatsu, Shizuoka

TEL

053-435-2279

Homepage URL

Email

inu@hama-med.ac.jp

Institute

Division of Vascular Surgery, Second Department of Surgery, Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

Division of Vascular Surgery, Second Department of Surgery, Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2016

Year

06

Month

16

Day

Date of IRB

2016

Year

06

Month

13

Day

Anticipated trial start date

2016

Year

11

Month

28

Day

Last follow-up date

2021

Year

05

Month

31

Day

Date of closure to data entry

2021

Year

05

Month

31

Day

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

11

Month

28

Day

Last modified on

2019

Year

07

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026237