There are over 400 million diabetics in the world, with numbers on the rise. 15% of all diabetics are prone to diabetic foot ulcers (DFU), a condition which can lead to skin breakdown, infection and, ultimately, amputation. There are 10 million people with diabetic foot ulcers in the world today. The outlook and impact of which are horrifying.
In the UK, more than 20 amputations take place per day. Mortality rates after DFU and amputation are high: up to 70% of people die within five years of an amputation and around 50% within five years of developing an ulcer. Besides the adverse effect on patients, diabetic foot ulcers and related complications are estimated to cost the NHS £1.13 billion per year. As such, avoiding amputations is key to increasing the quality of life for diabetics and improving survival rates.
Temperature is an early indicator of ulceration, prior to any visible signs or skin breakdown. It has been found that in the vulnerable skin area temperatures can rise by more than 1 °C. If this is detected correctly and early enough, doctors can intervene to protect the foot before ulceration occurs.
NPL’s team attracted a £1.2 million investment from the National Institute of Health Research: Product Development Award to develop a new device to meet this challenge. As a result of this investment, NPL’s team developed four clinical prototypes of a breakthrough medical imaging device called DFIRST.
The device helps podiatrists by generating temperature maps (thermography) of patients’ feet, to provide early alerts of potential problems. Such early detection would give more than a week’s extra time to take preventative action, reducing or even eliminating the ulceration and associated risk of infection.
The prototypes have now been through 2 years of registered multicentre randomised clinical trials, recording the data of hundreds of patients from healthy subjects to high risk diabetic patients. Performance testing of the DFIRST device was conducted at NPL; our expertise in the field of quantitative thermal imaging meant that the device was tested against rigorous standards ensuring it is as trustworthy as possible. This proves equivalence with the current gold standard and suitability for diabetic patients.
The prototypes have also been assessed by key opinion leaders and found to meet a significant societal need.
The DFIRST technology offers increased accuracy and speed as it is 10 times more precise than available imaging technology and a scan takes just seconds versus the several minutes offered by current single point devices. The device also has the ability to scan the entire foot, increasing the chance of early detection, as 60% of ulcers are not found on the sole of the foot.
The technology has since been spun out into a separate company, Celsius Health. Once taken to market, this technology will go on to impact millions of lives, reducing suffering and improving quality of life. Commercially it will create jobs and return millions of pounds to the economy. A 1% reduction in ulceration would save the NHS in the region of £10M.
Aligning with the trend in home monitoring, NPL’s DFIRST works fast and in a similar way to an ordinary camera meaning it is potentially suitable for home use, empowering patients in their own care and monitoring risk throughout the treatment pathway.
NPL is working to make sure this breakthrough in medical thermography can benefit other healthcare sectors. The technology could be deployed in many areas where monitoring and mapping temperature is key, such as Charcot foot (another serious and potentially limb-threatening lower-extremity complication of diabetes), reconstructive surgery, gauging an organ’s viability for transplant and tackling chronic wounds.
The value of the global wound care market is expected to reach $20.4 billion in 2021. Using its innovation in DFU, a common chronic wound, as a starting block, NPL is now looking to transform this market and the lives of those that live with chronic conditions.