First RCT to show improved walking capacity
First multi-centre randomized controlled trial using FlowOx™, published in Journal of Vascular Surgery, shows improved walking capacity for patients with intermittent claudication, also known as “windows shopper’s disease”.
In the first study of its kind, 72 patients were randomised to treatment with FlowOx™. Half of the group received treatment with FlowOx™, a novel pulsating negative pressure therapy, and the other half received a placebo treatment with a FlowOx™ sham device with no effect.
Results showed a significant change in walking capacity, favouring the group who used the active FlowOx.
“We believe this study is a pivotal milestone reached in our clinical program for FlowOx™. In addition to multiple studies showing increased blood flow, this study documents the long-term clinical effects of FlowOx use” says Iacob Mathiesen, PhD, Founder and Chief Scientific Officer, Otivio AS.
“This trial shows that FlowOx treatment may represent an effective and safe adjunct to standard care for patients with disabling peripheral artery disease”, says Henrik Hoel, MD, Department of Vascular Surgery, Oslo University Hospital.
Download the article from Journal of Vascular Surgery here!