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

October 30, 2013 updated by: Otivio AS
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 86 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 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™)
up to 1 hour

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Fitting time
Time Frame: up to 1 hour
up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otivio AS

Collaborators

The Research Council of Norway
European Union

Investigators

  • Principal Investigator: Jarlis Wesche, PhD, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • OT-FO-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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