Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg

Study Overview
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Brief Summary
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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.

Official Title
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Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg

Conditions
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Periferal Arterial Occlusive Disease, PAOD

Intervention / Treatment
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* Device: FlowOx


Participation Criteria
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Eligibility Criteria
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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.: 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 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FlowOx<br>5 minutes of pulsating negative pressure (10 sek og -40mmHg/7 sek of athmospheric pressure) will be Applied to the patient's leg | Device: FlowOx<br>* Boot-shaped pressure chamber generating pulsating negative pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of the prescribed cycles delivered in the specified time FlowOx™-induced change in arterial leg blood flow (LBF) | 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™) | up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort measured by asking the patient a fixed set of questions |  | up to 1 hour |