Project Summary
Diabetic Foot Ulceration is the most common complication of diabetes with the International Diabetes Federation estimating up to 26m ulcers develop each year. Up to 34% of the 422m people worldwide with diabetes will develop a foot ulcer during their lifetime. Half become infected and 20% lead to some level of amputation. In the UK 3.7m people have diabetes and over 60,000 people have an ulcer at any time, costing the NHS over £970m annually. Diabetes UK reports that 169 people undergo diabetes-related amputation each week in the UK, with 26,278 amputations from 2013-17, a 19.3% increase from 2010-13.

Management of foot ulcers is time-consuming and expensive with 45% taking more than six months to heal. Around 25% of patients re-ulcerate in 3 months, 40% within 1 year and 60% within 3 years. Patients who have achieved wound closure are generally considered to be in remission rather than healed.

Yet 80% of amputations can be prevented with the appropriate treatment, such as correctly fitting footwear. A patient presenting with a foot ulcer has a greatly elevated risk of amputation. Post wound-closure treatment is slow, expensive and ineffective. Patients require multiple visits to podiatrists to prescribe, fit and monitor therapeutic insoles and footwear. The footwear takes many months to fit, often without any acceptable alternative. It is expensive, bulky and difficult to wear, with poor compliance. This results in unacceptably high re-ulceration rates and many avoidable amputations. A faster, cheaper and more effective way to prevent re-ulceration is urgently needed.

ViscoTurf is a novel, 3D printed orthotic device designed specifically for this purpose. It emulates the function of natural turf to provide cushioning, optimised offloading and better micro-circulation on the plantar surface of the foot. This improves perfusion (the delivery of blood to the capillary bed) in the previously ulcerated regions where tissue damage has occurred and the risk of re-ulceration is very high. An earlier feasibility study established proof-of-concept, showing ViscoTurf achieved a higher and longer-lasting increase in perfusion compared to conventional support structures.

Project Status
We have developed proof-of-concept orthoses and successfully shown that these improve perfusion and a patent has been filed. The next stage of development is currently being planned.

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