Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA) and Academic Medical Center (AMC) in Amsterdam, the Netherlands, today announced their collaboration in a European multi-center 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 ischemia. Severe diabetic foot complications, which are the result of hampered blood circulation, affect millions of diabetic patients globally .
Amputation is one of the most important risks for patients with diabetic foot disease. At the moment, there is no diagnostic method to immediately assess the result of an angioplasty procedure - currently 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. In order to provide optimal care, there is therefore a clear need for a new diagnostic tool to assess treatment results more quickly. The European study in which Philips and AMC are collaborating will start in the summer of 2015 with final results expected in 2017.
This collaboration is being announced at the start of the 7th International Symposium on the Diabetic Foot, which takes place on the 20 - 23 May 2015 in The Hague, The Netherlands. More than 1,000 international clinical experts in the field of diabetes care are expected to attend the symposium and discuss the latest scientific developments.
“This could be a paradigm shift in our approach to critical limb ischemia,” said Professor Jim Reekers, interventional radiologist at AMC and fellow of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE). Over the past few months, he and his team have been testing the new technology and have already collected observational data from over 100 cases.
He added: “If we can predict the effect of treatment immediately after revascularization, 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 ischemia.”
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. Diabetes can impact the condition of the blood vessels and can lead to insufficient blood circulation, particularly in the legs and feet. In severe cases, known as critical limb ischemia, this can result in significant tissue damage (for example, ulcers and gangrene in the feet) and amputation. Restoration of blood flow from the major blood vessels into the network of small arteries and capillaries that transfer nutrients into the surrounding tissue (a process that is hampered) is vital for the healing process.
The current preferred treatment is 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-vascularization. In collaboration with AMC, Philips is developing a new technology to analyze perfusion angiography images and obtain quantitative information on blood flow in the capillaries (perfusion) in the foot.
Perfusion angiography is a novel 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 (DSA) 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 color-coded display. From this information a graphic representation can be obtained, which contains important information about the functioning of the micro-circulation.
“We are committed to improving the care that doctors can provide to their patients by innovating image-guided therapy procedures and maximizing their impact,” said Ronald Tabaksblat, business leader Image Guided Therapy Systems at Philips. “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. 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 personalized 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.”