Effect on Blood Flow Using the FlowOx™ Device in Patients... | NCT01893840

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

NCT01893840

Sponsor

Otivio AS

Status

Unknown status

Last Update Posted

Oct 31, 2013Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Periferal Arterial Occlusive Disease, PAOD

Interventions

FlowOx

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Jun 26, 2013

First Submission Date that Met QC Criteria

Jul 2, 2013

First Posted Date

Jul 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2013

Last Update Posted Date

Oct 31, 2013Estimated

Name	Class
European Union	OTHER
The Research Council of Norway	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FlowOx	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FlowOx	Device	Boot-shaped pressure chamber generating pulsating negative pressure	FlowOx

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
% of the prescribed cycles delivered in the specified time FlowOx™-induced change in arterial leg blood flow (LBF)	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 Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Fitting time		up to 1 hour

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided