UMIN-CTR Clinical Trial

Basic information
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
Condition	Peripheral Arterial Disease
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

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	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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
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

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	2016 Year 11 Month 28 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	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
Other related information

Management information
Registered date	2016 Year 11 Month 28 Day
Last modified on	2019 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026237