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

June 26, 2013
October 30, 2013
August 2013
December 2013   (final data collection date for primary outcome measure)
% 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™)
Same as current
Complete list of historical versions of study NCT01893840 on ClinicalTrials.gov Archive Site
Patient comfort measured by asking the patient a fixed set of questions [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
Same as current
Fitting time [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]
Same as current
 
Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Periferal Arterial Occlusive Disease, PAOD
Device: FlowOx
Boot-shaped pressure chamber generating pulsating negative pressure
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
Intervention: Device: FlowOx
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
30 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01893840
OT-FO-01
No
Otivio AS
Otivio AS
  • European Union
  • The Research Council of Norway
Principal Investigator: Jarlis Wesche, PhD Principal Investigator
Otivio AS
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP