The FlowOx system may improve patient outcomes and reduce treatment costs.
More than 210 million individuals around the world have peripheral arterial disease (PAD), which is caused by fatty deposits blocking the arteries in the legs.
In mild cases, PAD is characterized by severe pain, while more serious cases are characterized by pain and leg ulcers that do not heal. Many patients with serious PAD must have their affected leg amputated due to infection.
Investigators at the University of Salford recently received a grant to conduct a clinical trial of the FlowOx system, created by Otivio, to prevent amputations among these patients, according to a press release.
The device is a boot-shaped chamber that creates a mild suction when the leg is inside. This mechanism is thought to draw blood past the blocked artery and into the limb, with a goal of improved wound healing.
The investigators plan to include 15 patients with PAD in the LLIFT clinical trial. Of these patients, 10 will use the novel device for 2 hours per day over 3 months, while a control group of 5 patients will continue normal care.
Blood pressure, pain, and wound healing will all be monitored during the trial. Additional questionnaires will measure participants’ quality-of-life, such as how easily they can walk and carry out day-to-day activities, according to the release.
In the future, the scientists hope that they will able to use medical imaging techniques to study how the FlowOx system affects the blood vessels.
“The main issue is people’s quality of life, as the pain they experience is debilitating — they can’t walk without experiencing pain in their legs and they often can’t sleep,” said lead researcher Farina Hashmi, PhD. “The device has already gone through some testing, with some very encouraging results, but like any clinical trial we don’t know what we’re going to find. However, even if it just means that the pain levels are reduced, the impact of that for millions of people could be huge.”
More than 27 million people in Europe and North American have PAD, but it is increasingly prevalent in developing countries in the Pacific and South East Asia, according to the release.
A team of researchers at Bangor University is planning to do a health economics assessment of participants, which will explore the costs associated with treatment and how much it costs to miss work or travel to appointments. Then, they will analyze the savings from avoiding amputations and adverse health events.
If the results are positive, this system may be able to reduce amputations from other conditions that are characterized by slow healing of the legs, such as diabetes.
“The University of Salford and Bangor University have been selected as partners for this study because of their very good reputation and high quality of research,” said Iacob Mathiesen, PhD, CSO at Otivio. “On the pathway of providing a novel treatment to a large and growing patient population, we see them as ideal partners for documenting the effects of FlowOx.”