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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Treatment is done by the patient at home for about 2 hours per day. Recommended to be 1 hour in the morning and 1 hour in the afternoon.
Treatment is done by the patient at home for about 2 hours per day. Recommended to be 1 hour in the morning and 1 hour in the afternoon.
Franziskus-Krankenhaus Berlin
Berlin, Germany
Evangelisches Krankenhaus Hubertus, Gefäßzentrums Berlin-Brandenburg
Berlin, Germany
Gemeinschaftspraxis
Ettlingen, Germany
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, Germany
Universitätsmedizin Johannes Gutenberg Universität
Mainz, Germany
Change in pain-free walking distance from baseline to week 12
The change will be calculated as difference in meters and compared between the interventional and the sham group.
Time frame: baseline to week 12
Change in maximal walking distance from baseline to week 12
The change will be calculated as difference in meters and compared between the interventional and the sham group.
Time frame: 3 months treatment
Change in Ankle Brachial index from baseline to week 12
Determination of the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium)
Time frame: from baseline to week 12
Change in Quality of Life from baseline to week 12: EQ-5D-5L
The 5-level EQ-5D (EuroQol- 5 Dimension) version (EQ-5D-5L) essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). EQ-5D-5L describes the health condition of adults in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). Patient indicate their health states by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ-VAS score is read on a scale of 0-100 points (scale name: health condition), depending on where the patient has set his mark. 0 points mean the worst possible health condition, while 100 points is the best health possible.
Time frame: from baseline to week 12
Change in activity of daily living from baseline to week 12
To evaluate the activity of daily living the standardized questionnaire VascuQoL-6 is used which comprises a set of 6 questions. Each question is scored 1-4. The sum of each individual question score is used to generate a "Total" Score. A higher value indicates better health status.
Time frame: from baseline to week 12
Determination of compliance of subjects as assessed by the time the device has been running
The FlowOx device records the time the device has been running each time it was started. This record is saved on an USB stick which is readable by the study personnel only and serves to document the patient's compliance.
Time frame: at week 12
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