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

Otivio

Status: Unknown

Conditions: Periferal Arterial Occlusive Disease, PAOD

Treatments: Device: FlowOx

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01893840

OT-FO-01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

FlowOx

Experimental group

Description:

5 minutes of pulsating negative pressure (10 sek og -40mmHg/7 sek of athmospheric pressure) will be Applied to the patient's leg

Treatment:

Device: FlowOx