Overview

This trial is active, not recruiting.

Condition periferal arterial occlusive disease, paod
Treatment flowox
Sponsor Otivio AS
Collaborator European Union
Start date August 2013
End date December 2013
Trial size 20 participants
Trial identifier NCT01893840, OT-FO-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
5 minutes of pulsating negative pressure (10 sek og -40mmHg/7 sek of athmospheric pressure) will be Applied to the patient's leg
flowox
Boot-shaped pressure chamber generating pulsating negative pressure

Primary Outcomes

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

Secondary Outcomes

Measure
Patient comfort measured by asking the patient a fixed set of questions
time frame: up to 1 hour

Eligibility Criteria

Male or female participants from 30 years up to 90 years old.

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

Additional Information

Official title Effect on Blood Flow Using the FlowOx™ Device in Patients With Reduced Peripheral Circulation in the Lower Leg
Principal investigator Jarlis Wesche, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Otivio AS.