NCT04100681

Intermittent Negative Pressure; Impact on Peripheral Artery Disease and Intermittent Claudication

Intermittent Negative Pressure to Improve Peripheral Blood Flow in Patients With Peripheral Artery Disease and Intermittent Claudication

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Otivio AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral Vascular Disease
• Intermittent Claudication
• Walking, Difficulty
• Critical Limb Ischemia
• Ischemia Limb

Interventions

Type	Name	Description
DEVICE	Active FlowOx™	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.
DEVICE	Sham FlowOx™ (Placebo)	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.

Timeline

• Start date: 2019-08-19
• Primary completion: 2020-04-01
• Completion: 2020-05-31
• First posted: 2019-09-24
• Last updated: 2020-08-25

Locations

5 sites across 1 country: Germany