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

NATerminatedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

August 19, 2019

Primary Completion Date

April 1, 2020

Study Completion Date

May 31, 2020

Conditions
Peripheral Vascular DiseaseIntermittent ClaudicationWalking, DifficultyCritical Limb IschemiaIschemia Limb
Interventions
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.

Trial Locations (5)

10787

Franziskus-Krankenhaus Berlin, Berlin

14129

Evangelisches Krankenhaus Hubertus, Gefäßzentrums Berlin-Brandenburg, Berlin

37075

Universitätsmedizin Göttingen Georg-August-Universität, Göttingen

55131

Universitätsmedizin Johannes Gutenberg Universität, Mainz

76275

Gemeinschaftspraxis, Ettlingen

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

mediq Innovation Experts GmbH

UNKNOWN

collaborator

Hannover Medical School

OTHER

lead

Otivio AS

INDUSTRY