At present every 30 seconds somebody in the world undergoes a lower limb amputation as a direct result of diabetes
A WETHERBY company could hold one of the keys to unlocking a complex health problem that is the prime cause of amputation among the UK’s growing number of people with diabetes – and drains the NHS of £2m of taxpayers’ money every day.
Autonomed has pioneered a revolutionary insole that was originally developed to soothe the aching and tired feet of employees who are exposed to prolonged periods of standing or walking at work
But new research by doctors searching for an answer to one of the medical world’s biggest challenges has unearthed a more far-reaching use for the invention – that the gel-filled insole could be an all-important breakthrough in preventing foot ulcers among Britain’s near 4m people who suffer from diabetes, a figure rising with another UK sufferer being diagnosed every three minutes.
The globally patented insoles, known as Liqua Care, have been pioneered by Autonomed Ltd, based at Bramham, near Wetherby. Its managing director David Watt saw his late father suffer amputation of both legs as a result of poor circulation due to vascular disease.
This research is of far-reaching importance for a diabetes community which is growing at a rate of 100,000 people each year and also the increasing population with vascular disease. It could transform their care – saving taxpayers’ money, reducing the risk of ulcers and amputation and quite literally, potentially saving lives.
As well as the proven medical benefits, there is also the practical and cost advantage of the insoles’ design – their slimline profile allows them to be easily inserted into a patient’s non-prescription footwear with no need for modification.
The research was carried out by seven of Scotland’s leading medical and academic experts and their results – recently published in The British Journal of Diabetes and Vascular Disease – are now sparking worldwide interest in the insole, formally accredited as a Class 1 Medical Device.
A group of patients with diabetes aged between 40 and 77 took part in the clinical trial. Tests showed that by wearing the insoles:
Forefoot pressure – a major cause of ulcers – was immediately reduced by 21.5 per cent.
Oxygen flow – after less than two weeks’ use, oxygen flow to the tissues of the feet had improved by a “clinically-significant” 5 per cent.
What is stirring interest among those involved in diabetes care is that this is the first time that an insole has been proved to enhance circulation. These findings have been demonstrated after only a short period of wear time – and the article states that the blood flow should improve still further if worn over a longer period of time.
Mr Duncan Stang, National Diabetes Foot Care Coordinator for Scotland, who is based at Hairmyres Hospital in East Kilbride, is co-author of the findings.
Around one in six people with diabetes will suffer from foot ulceration in their lifetime and it is estimated that 80% of amputations in people with diabetes are preceded by a foot ulcer. So if we can reduce the incidence of foot ulceration, we will be able to lower the amputation rate.
A lot of time and money has been spent over the years searching for ways of preventing the serious complication of a foot ulcer. This research shows that these insoles could be a simple and cost-effective way of achieving this.
With the number of people with diabetes poised to double by 2025, foot ulcers are recognised as a global issue of major economic importance and any form of preventative treatment or management should be looked at very closely.
The amputation rate among people with diabetes has long been an area of concern for Diabetes UK, whose Chief Executive, Douglas Smallwood, said: “This situation is shocking given that most amputations can be prevented with better awareness and management of the condition.” Only this month Diabetes UK (Scotland) issued a press release which commenced “One in four people with diabetes in Scotland are at increased risk of amputation because they have not had a foot check”
Hospitalisation of a patient with diabetes is more likely to occur as a result of foot disease than all the other complications of diabetes put together– with a resulting healthcare cost amounting to some 20 per cent of the £3.5 billion that the NHS spends on diabetes each year.
The insoles contain a precisely-measured non-toxic liquid that flows through a patented system with anatomically-designed channels controlling the direction of the liquid. This ensures directional stability while walking or standing-up, and matches the flow of the liquid to the structure of the foot.
The researchers are now exploring ways of building on their initial project by exploring ways of carrying out a larger trial a longer period of time to add further weight to their findings.
Full details of the ground breaking research can be found here: http://dvd.sagepub.com/content/11/2/80.full.pdf+html
The Scottish clinical and academic team that led the research project …..back row (from left) Dr Tamim Siddiqui, from the Department of Vascular Surgery, Hairmyres Hospital, East Kilbride; Raymond Hamill, a member of the Research and Development team at NHS Lanarkshire and based at Monklands Hospital in Airdrie; William Munro, Orthotist from the Diabetes Centre at Hairmyres Hospital and the National Centre for Prosthetics and Orthotics at the University of Strathclyde in Glasgow. Front row (from left) Mr Donald Bain, Vascular Consultant, from the Diabetes Centre and the Department of Vascular Surgery, Hairmyres Hospital; Duncan Stang, Advanced Specialist Podiatrist from the Diabetes Centre at Hairmyres Hospital who is National Diabetes Foot Coordinator for Scotland.