UMIN-CTR Clinical Trial

Basic information
Public title	A study on the clinical usefulness of tissue oxygenation monitoring with OX Imager for peripheral arterial occlusive disease (PAD)
Acronym	A study on the clinical usefulness of tissue oxygenation monitoring with OX Imager for peripheral arterial occlusive disease (PAD)
Scientific Title	A study on the clinical usefulness of tissue oxygenation monitoring with OX Imager for peripheral arterial occlusive disease (PAD)
Scientific Title:Acronym	A study on the clinical usefulness of tissue oxygenation monitoring with OX Imager for peripheral arterial occlusive disease (PAD)
Region	Japan

Condition
Condition	peripheral arterial disease
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Conventionally, the non-invasive blood flow evaluation method of limb arterial disease such as obstructive arteriosclerosis or 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 (SPP) and percutaneous oxygen partial pressure (TcPO 2) have also been clinically applied. However, these tests were time consuming and painful in some cases. OX Imager (manufactured by modulated Imaging, USA) can measure oxygen metabolism information of oxygen saturation, oxygenated hemoglobin concentration, deoxygenated hemoglobin concentration inside living tissue quantitatively and as an image without contacting the living body It is a possible device. We will evaluate the blood flow of the ischemic limb using this device and consider the correlation with the conventional method ABI and the comparison with the conventional method with TcPO 2 and SPP.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	q
Key secondary outcomes

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	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Shoot foot with OX Imager. Record the values of blood oxygen saturation (StO 2), oxyhemoglobin (HbO 2), deoxyhemoglobin (HbR) of tissues obtained by photographing. The inspection time is about 30 seconds. The patient has no adverse effect at all.
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	Persons who aged 20 or over and under 80 are aged acquisition days. Person who consented to participate in this research in document Healthy volunteers Patients with peripheral artery disease
Key exclusion criteria	Persons who may have pregnancy and pregnancy Person who the researcher judged inappropriate People who can not obtain consent to participate in this research
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Naoki Middle name Last name Unno
Organization	Hamamatsu University School of Medicne
Division name	Second Deparment of Surgery
Zip code	431-3192
Address	1-20-1,Handayama,Higashi-ku,Hamamatsu city,Shizuoka prefecture,Japan
TEL	0534352111
Email	d16007@hama-med.ac.jp

Public contact
1st name of contact person	1st name Takafumi Middle name Last name Kayama
Organization	Hamamatsu University School of Medicne
Division name	Second Deparment of Surgery
Zip code	431-3192
Address	1-20-1,Handayama,Higashi-ku,Hamamatsu city,Shizuoka prefecture,Japan
TEL	0534352111
Homepage URL
Email	d16007@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicne Second Deparment of Surgery
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicne Second Deparment of Surgery
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	Clinical Research Review Board of Hamamatsu University School of Medicine
Address	1-20-1,Handayama,Higashi-ku,Hamamatsu city,Shizuoka prefecture,Japan
Tel	0534352111
Email	kenkyou.s@hama-med.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	17-006
Org. issuing International ID_1	Hamamatsu University School of Medicine Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	浜松医科大学　第二外科

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 06 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	2017 Year 04 Month 01 Day
Date of IRB	2017 Year 04 Month 04 Day
Anticipated trial start date	2017 Year 04 Month 04 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 09 Month 06 Day
Last modified on	2019 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031138