Royal Philips and Academic Medical Center (AMC) in Amsterdam, the Netherlands, have announced their collaboration in a European multicentre clinical study to investigate a new diagnostic technique targeting immediate assessment of the results of a minimally-invasive treatment for diabetic foot and critical limb ischaemia.
Amputation is one of the biggest risks for patients with diabetic foot disease. Currently, there is no diagnostic method to immediately assess the result of an angioplasty procedure—the preferred treatment option to restore blood circulation in the foot. The result is typically only determined months after treatment by following the progress of the healing process or lack of it. The European study in which Philips and AMC are collaborating will start in the summer of 2015 with final results expected in 2017.
“This could be a paradigm shift in our approach to critical limb ischaemia,” said Jim Reekers, interventional radiologist at AMC and fellow of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), whose team have been testing the new technology and have collected observational data from over 100 cases.
He added: “If we can predict the effect of treatment immediately after revascularisation, then we will have a head start in developing a pro-active care plan for the patient’s recovery at home, instead of a more reactive approach. The first observations using the new diagnostic technique are consistent and promising, and have already provided valuable insights into many pending questions regarding critical limb ischaemia.”
Globally, the International Diabetes Federation estimates that 387 million people are living with diabetes and that this figure will almost double in the next twenty years. The current preferred treatments for severe cases which result in critical limb ischemia are image-guided minimally invasive treatments such as angioplasty to re-open the major blood vessels in the foot with the objective of restoring the flow to the micro-circulation. Under live interventional X-ray guidance, a catheter is inserted into a blood vessel in the leg and navigated to the foot in order to re-open the major blood vessels with a balloon and/or a stent. Perfusion angiography is used to obtain a map of the vascular network in the foot. However, until now, it has not been possible to image the function of the micro-circulation, making it difficult to determine the immediate impact of the procedure on the micro-vascularisation. In collaboration with AMC, Philips is developing a new technology to analyse perfusion angiography images and obtain quantitative information on blood flow in the capillaries in the foot.
Perfusion angiography is an X-ray imaging technology that exploits the high temporal and spatial resolution of X-ray angiographic images. Philips’ new software assesses subtle physiological changes in the perfusion level. The perfusion image can be constructed from a standard digital subtraction angiography performed using a Philips AlluraXper FD20 system, meaning that no additional patient exposure to radiation or contrast agent is needed. The generated perfusion image shows the physiological perfusion state as a colour-coded display. From this information a graphic representation can be obtained, which contains important information about the functioning of the micro-circulation.
“Diabetes is already the leading non-trauma cause of amputation, and prevalence of the condition is widely predicted to increase significantly in the coming years,” said Ronald Tabaksblat, business leader Image Guided Therapy Systems at Philips. “Currently, millions of people with diabetes globally are at risk of suffering a lower-limb amputation. As a new instrument for image-guided therapy, perfusion angiography could usher in a new age of precision personalised treatment for diabetic patients that suffer from severe foot complications—improving their quality of life and mobility while helping to reduce diabetes-related healthcare costs.”