Status:
UNKNOWN
Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg
Lead Sponsor:
Otivio AS
Collaborating Sponsors:
European Union
The Research Council of Norway
Conditions:
Periferal Arterial Occlusive Disease, PAOD
Eligibility:
All Genders
30-90 years
Phase:
NA
Brief Summary
A study to assess the effect of negative pulsating pressure therapy on patients with impaired blood flow to the leg caused by arterial disease, to see if the FlowOx device will increase the blood flow...
Eligibility Criteria
Inclusion
- Written Informed Consent
- 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.:
- 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)
- 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)
- 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
- Grade 1 PAOD
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01893840
Start Date
August 1 2013
End Date
December 1 2013
Last Update
October 31 2013
Active Locations (1)
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1
Akershus University Hospital
Lørenskog, Lørenskog, Norway, N-1478