Periferal Arterial Occlusive Disease, PAOD
Conditions
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 to the leg in these patients.
Interventions
DEVICEFlowOx
Boot-shaped pressure chamber generating pulsating negative pressure
Sponsors
European Union
The Research Council of Norway
Otivio AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.: 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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % of the prescribed cycles delivered in the specified time FlowOx™-induced change in arterial leg blood flow (LBF) | up to 1 hour | This is calculated as the difference between the blood flow during the period using FlowOx™ (middle value over a period of 5 minutes) and baseline blood flow (middle value over a period of 5 prior to using FlowOx™) |
Secondary
| Measure | Time frame |
|---|---|
| Patient comfort measured by asking the patient a fixed set of questions | up to 1 hour |
Other
| Measure | Time frame |
|---|---|
| Fitting time | up to 1 hour |
Countries
Norway
Outcome results
None listed