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

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.

Study Overview

• Status: Unknown
• Conditions: Periferal Arterial Occlusive Disease, PAOD
• Intervention / Treatment: Device: FlowOx

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Lørenskog, Norway, N-1478
    • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FlowOx; 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; Boot-shaped pressure chamber generating pulsating negative pressure

What is the study measuring?

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	Time Frame
Patient comfort measured by asking the patient a fixed set of questions	up to 1 hour

Other Outcome Measures

Outcome Measure	Time Frame
Fitting time	up to 1 hour

Collaborators and Investigators

• Sponsor: Otivio AS
• Collaborators: The Research Council of Norway; European Union
• Investigators: Principal Investigator: Jarlis Wesche, PhD, Principal Investigator

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 9, 2013

Study Record Updates

• Last Update Posted (Estimate): October 31, 2013
• Last Update Submitted That Met QC Criteria: October 30, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: OT-FO-01