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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
European Union
The Research Council of Norway
Information provided by (Responsible Party):
Otivio AS
ClinicalTrials.gov Identifier:
NCT01893840
First received: June 26, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Periferal Arterial Occlusive Disease, PAOD
Device: FlowOx

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg

Further study details as provided by Otivio AS:

Primary Outcome Measures:
  • % of the prescribed cycles delivered in the specified time FlowOx™-induced change in arterial leg blood flow (LBF) [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Patient comfort measured by asking the patient a fixed set of questions [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Fitting time [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893840

Locations
Norway
Akershus University Hospital
Lørenskog, Norway, N-1478
Sponsors and Collaborators
Otivio AS
European Union
The Research Council of Norway
Investigators
Principal Investigator: Jarlis Wesche, PhD Principal Investigator
  More Information

No publications provided

Responsible Party: Otivio AS
ClinicalTrials.gov Identifier: NCT01893840     History of Changes
Other Study ID Numbers: OT-FO-01
Study First Received: June 26, 2013
Last Updated: October 30, 2013
Health Authority: Norway: Directorate of Health

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014