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

NCT01893840 | Unknown

• 1 other identifier: OT-FO-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periferal Arterial Occlusive Disease, PAOD

Outcome Measures

Primary Outcomes (1)

• % 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 Outcomes (1)

• Patient comfort measured by asking the patient a fixed set of questions

  up to 1 hour

Other Outcomes (1)

• Fitting time

  up to 1 hour

Study Arms (1)

FlowOx

EXPERIMENTAL

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

Interventions

FlowOx DEVICE

Boot-shaped pressure chamber generating pulsating negative pressure

FlowOx

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Otivio AS: lead
• European Union: collaborator
• The Research Council of Norway: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, Lørenskog, N-1478, Norway

Location

Study Officials

• Jarlis Wesche, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 9, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

NO (1)