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Evaluation of usefulness of blood flow measurement device

Not Applicable
Conditions
arteriosclerosis obliterans (ASO) or suspection of the ASO
arteriosclerosis obliterans
I7020
Registration Number
JPRN-jRCTs032200072
Lead Sponsor
Horinaka Shigeo
Brief Summary

Flow volumes measured by the electrical impedance plethysmography (EIP) of the lower extremity in the venous occlusion principal and by the doppler duplex ultrasound in the popliteal artery were well correlated. EIP might be able to measure whole lower extremity arterial flow including collateral flow in patients with lower extremity artery disease (LEAD). EIP reflected LEAD more significantly than the Doppler ultrasound method.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
50
Inclusion Criteria

1. Patients with atherosclerosis obliterans (ASO) or suspection of the ASO.
2. Patients are more than 20 years old and less than 90 years old.
3. Patients are given sufficient written explanations of the study and written informed consent.

Exclusion Criteria

1. Patients cannot measure blood flow by the ultrasonography.
2. Patients are Performance Status 4.
3. Patients had implantable devices such as pacemakers.
4. Patients had scars or inflammation on the attachemnet site of the electrodes.
5. Patients are pregnants or doubt of the pregnancy.
6. Patients are considered inappropriate participants in this study by the investigators.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparative evaluation of blood flow in non-invasive blood flow test device and ultrasonic doppler blood flow test
Secondary Outcome Measures
NameTimeMethod
1. Comparison between ABI (ankle-brachial pressure index) and lower limb blood flow by non-invasive blood flow test device<br>2. Comparison between imaging by CT or MRI and lower limb blood flow by non-invasive blood flow test device
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