Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg
NCT ID: NCT01893840
Last Updated: 2013-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2013-08-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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FlowOx
5 minutes of pulsating negative pressure (10 sek og -40mmHg/7 sek of athmospheric pressure) will be Applied to the patient's leg
FlowOx
Boot-shaped pressure chamber generating pulsating negative pressure
Interventions
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FlowOx
Boot-shaped pressure chamber generating pulsating negative pressure
Eligibility Criteria
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Inclusion Criteria
* Age 30-90 years
* Affected foot/shoe sise less than 46 (approximate foot length less than 29.5 cm)
* Patients with Peripheral Arterial Occlusive Disease (PAOD) grade 2,3 or 4, i.e.:
1. Clinically verified grade 2, i.e. Intermittent Claudication:
* Ancle-Brachial Index (ABI)less than 0.9 or
* Toe brachial Index (TBI) less than 0.7 or
* Ultrasound and/or CT/Magnetic Resonance (MR) angiography suggesting stenosis(es)and/or occlusion(s)
2. Clinically verified grade 3, i.e. Critical Limb Ischemia (CLI):
* ABI less than 0.4 or
* Toe pressure less than 30 mmHg
* Rest pain since at least 2 weeks or
* Use of analgesics for rest pain for at least 2 weeks or
* Ultrasound and/or CT/Magnetic Resonance (MR) angiography suggesting stenosis(es)and/or occlusion(s)
3. Clinically verified grade 4, i.e. CLI:
* Ischemic ulcers or gangrene/tissue loss
* ABI less than 0.4
* Toe pressure less than 30 mmHg
* Rest pain since at least 2 weeks or
* Use of analgesics for rest pain for at least 2 weeks or
* Ultrasound and/or CT/MR angiography suggesting stenosis(es)and/or occlusion(s)
Exclusion Criteria
* Incapable of consenting voluntarily
* Fewer higher than 39 degrees Centigrade
* Severe Chronic Obstructive Pulmonary Disease (COPD)
* Severe heart disease such as unstable angina, severe heart failure and severe valve failure
* Severe Polyneurophathy
* Verified Osteomyelitis other than in the Phanlanx
* Currently treated for cancer and With a life expectancy of less than 2 years
30 Years
90 Years
ALL
No
Sponsors
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European Union
OTHER
The Research Council of Norway
OTHER
Otivio AS
INDUSTRY
Responsible Party
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Principal Investigators
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Jarlis Wesche, PhD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Akershus University Hospital
Lørenskog, Lørenskog, Norway
Countries
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Other Identifiers
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OT-FO-01
Identifier Type: -
Identifier Source: org_study_id