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

O

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.:

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:

  • 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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