Researchers are testing a home care device which could help millions of people suffering from an agonising condition and save the need for leg amputations.
The University of Salford has received a £396,000 EU grant to carry out a clinical trial into the FlowOx™ system, designed to help people suffering from peripheral arterial disease (PAD).
An estimated 210 million people around the world suffer from the condition, caused by a build-up of fatty deposits in the arteries providing blood to the legs.
Mild cases of the disease, associated with heart disease, cause severe pain when walking while more serious cases cause debilitating pain along with leg ulcers which do not heal and become so badly infected – and even gangrenous – that the leg has to be amputated.
Researchers from the University’s Health Science School will now look into the effectiveness of the FlowOx™ device, created by Norwegian company Otivio to manage the condition.
The device, a boot-shaped chamber which sufferers rest the affected leg inside, creates a mild suction effect to draw blood past the blocked artery and into the limb –reviving tissue and enabling wounds to heal.
The researchers will be conducting a feasibility study on 15 people from across the North West suffering from severe cases of the disease (the LLIFT study).
Ten people will use the device at home for up two hours a day over a three month period while the others will continue to receive normal clinical care.
The University’s researchers will measure factors such as blood pressure, how much pain they are experiencing and how quickly their wounds are healing, while they will also ask detailed questions to assess the patients’ quality of life such as how easily they are able to walk and carry out daily activities.
The team also hopes to carry out further work using medical imaging techniques to understand what effect the system has on patients’ blood vessels.
Dr Farina Hashmi, University of Salford lecturer in Podiatry and research lead, said: “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.
“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.”
Around 27m people in Europe and North America are affected by the disease, but it is more prevalent in developing countries in the Pacific and South East Asia.
Another team at Bangor University will carry out a health economics assessment on those taking part in the trial, looking at everything from the cost to the NHS for treating the disease to the cost to patients of having to give up work and travel to appointments.
They will then assess the potential savings which could be made if patients could manage the condition effectively using the FlowOx™ system.