Title: Developing commercialisation potential of our patented point-of-care neuropathy assessment device
Funder: Department of Health and Social Care

Abstract: Peripheral neuropathy is an increasingly common condition affecting 2.3 million people in the UK (4.5% of the population), and can lead to loss of sensation in fingers and toes. It has many causes but mainly due to diabetes, in which it affects about 60% of patients with diabetes worldwide. Loss of sensation in the feet, together with poor vascular perfusion, can lead to ulceration and amputation. Diabetes UK reports that diabetes-related amputations in England have reached an all-time high of 135/week or more than 7000/year. They advocate that with good diabetes and footcare up to 80% of these amputations can be avoided. NICE guidelines recommend regular foot surveillance, at least annually and then more frequently, to reduce morbidity by prompt treatment. However, diabetic neuropathy may be asymptomatic and remain undiagnosed for several years, so regular screening is vital to identify the at-risk foot. Currently, patients with peripheral neuropathy have to travel to hospital annually and have no way of self-testing. Such infrequent assessment can lead to under-recognition of neuropathy and harm to the patient. Our solution is a patented smartphone based point-of-care testing (POCT) device for diagnosis and grading of peripheral neuropathy. The device uses the vibration motor within a smart-phone, controlled by our developed app and applied through an attachment probe to grade the sensory reduction related to neuropathy. Our scientific endeavour is therefore focused on (i) conducting a clinical study on patients with varying levels of neuropathy to evaluate the device, (ii) developing an app and the calibration software to support a wider range of smartphones (iPhone, Android, Windows), (iii) producing a wide range of attachment probes and investigating one size fits all, (iv) stakeholder engagement to identify commercialisation opportunities (v) conduct an economic analysis to inform the commercialisation plan

Lay abstract: Around 2.3 million people in the UK (4.5% of the population) have uncomfortable tingling and prickling in their feet and fingers often caused by diabetes or cancer treatment. The most common cause is diabetes where it can progress to loss of sensation leading to skin ulceration and amputation (currently over 7,000 amputations per year in the UK). Diabetes UK suggests that with good diabetic and foot care up to 80% of these amputations can be avoided. NICE (National Institute for Health and Care Excellence) guidelines recommend regular foot check-ups, at least annually and then more frequently for prompt treatment and improved results. Unfortunately, patients cannot test themselves and the early nerve disease may not have any symptoms, therefore remain undetected for several years. Thus, regular screening of nerve function in people with diabetes is an unmet need. Nerve damage can also occur acutely during treatment for cancer; a measure of nerve function in these patients could guide how much drug is given in relation to harmful side-effects. We are aiming to find a solution to this problem using smart-phones to assess sensation loss at the patient s home. This will benefit patients from reduced travelling to appointments and the associated costs but also reassuring them that a diagnosis won t be missed and their condition is regularly monitored. The device will use the vibratory motor within smart-phones, controlled by our app, applied through an attachment. The device is placed on the feet and hands by the patient, or a carer, and the intensity of vibration is altered automatically. Vibration perception can reflect the underlying nerve conditions. Patients have to say when they begin to feel the vibration as it is increased. Any reduction in feeling the vibration can be compared with people of the same age and against each patient s previous results. In this way early nerve damage can be determined. The measurements will be transferred to clinicians through our smart phone app to an online patient database. That way &ndash; for the first time &ndash; we will have data on patient s nerve function, from home, with repeated measures to alert for early damage and allow prompt treatment. We have involved patients and carers in the development of this device. During testing of the device several patients expressed their fear of losing their foot due to their disease, and the huge impact this would have on their life. They thought that a device that monitored their foot condition would enable them take tighter management of their diabetes in a timely manner. We aim to make this device available to patients once the necessary approvals have been obtained. To support this we will conduct an economic analysis to inform its commercial case.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: NEUROLOGICAL