UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025021 |
|---|---|
| Receipt number | R000026237 |
| Scientific Title | Evaluation of tissue blood flow for limb ischemia by finger-mounted tissue oximetry |
| Date of disclosure of the study information | 2016/11/28 |
| Last modified on | 2019/07/19 15:10:54 |
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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
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
inu@hama-med.ac.jp
Sponsor or person
Institute
Division of Vascular Surgery, Second Department of Surgery, Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026237
