Critical Limb Ischemia Clinical Trial
Official title:
Intermittent Negative Pressure to Improve Peripheral Blood Flow in Patients With Peripheral Artery Disease and Intermittent Claudication
The objective is to ensure the pro-active collection of information on quality, safety and performance of FlowOx™ after it is placed on the market. The study will be carried out in a patient population with peripheral artery disease (claudicatio intermittens) to confirm its usefulness and in particular gather information for further improvements of the device related to this patient population. The data collected from the use of the CE-marked FlowOX™ device are change of walking distance, quality of life, and the patient's compliance.
A multi-center, randomized, sham (placebo)-controlled, double-blind trial to assess the
efficacy and safety of FlowOx. This is done by comparing the increase in pain free walking
distance compared to sham (placebo) device in patients with peripheral arterial disease (PAD)
and intermittent claudication.
This study is conducted to assess the efficacy and safety of FlowOx™ compared to a sham
FlowOx™ (placebo) device treatment. FlowOx™ can provide intermittent negative pressure (up to
- 40 mmHg INP [intermittent negative pressure]) which is known to improve blood flow. The
same device will also work as a sham (placebo) device by less negative pressure exerted by
the device (in the range of -10 mmHg).
Daily home use of FlowOx™ for 2 hours (divided into minimum two sessions of 1 hour) per day
in PAD-patients with intermittent claudication (stage II acc.to EMA, equivalent to Fontaine
stage IIb in Germany) relative to sham (placebo) will be provided over a period of 12 weeks.
This efficacy study is evaluating the clinical effects of INP on patient with intermittent
claudication with special focus on changes in pain free walking distance and quality of life.
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