Avoiding serious complications through early detection

Over 70,000 people in the UK have a foot ulcer at any one time. The cost of treating a foot ulcer for one year is a staggering £7,000.1

Our NHS spends over £700 million per year on treating foot ulcers and performing amputations. And that excludes knock-on social and economic costs.

Dryness of the skin of the feet assessed by the neuropad® screening test correlates with the potential for foot ulceration.2

What this means is that neuropad® may pick up diabetes-related foot problems early so that more serious complications may be avoided through initiation of timely treatment.

neuropad® is an evidence-based medical device

neuropad® has been studied extensively

For example, a study involving 379 patients with diabetes has shown that dryness of the skin of the feet correlates with foot ulceration.2 Subclinical sudomotor dysfunction can be detected early in diabetes, even in subjects with normal nerve conduction velocities. This study showed that dryness of the skin of the feet was detected in 95% of the patients with foot ulceration using the neuropad® test. An abnormal neuropad® response correlated with foot ulceration in subjects with diabetes. Patients with foot ulceration had more severe peripheral neuropathy and more often an abnormal neuropad® response. Multivariate statistical analysis demonstrated that patients with diabetes with an abnormal neuropad® response are 16 times more likely to develop foot ulceration compared to those with a normal neuropad® test result. 2 The neuropad® screening test has what is known as high SENSITIVITY . In clinical trials, the sensitivity and specificity of neuropad® was comparable to that of  well-established hospital-based tests.

Published clinical studies list

neuropad® is a categorical non-subjective test

Having a high sensitivity means that when the test is carried out a high proportion of people tested have a positive result subsequently confirmed by hospital-based tests. In clinical studies, this has ranged from 70%-86%. In line with most screening tests, neuropad® has a lower rate of specificity (the proportion of people with a negative result who do not have peripheral autonomic neuropathy) which is typical for a screening test.

The principle behind the neuropad® screening test is that it may detect potential problems several years before conventional tests for peripheral autonomic neuropathy are able to. This is because only when damage to the small and large nerve fibres in your feet has affected your ability to feel sensation – for example when prodded with monofilament or put into direct content with a tuning fork – will problems be detectable. Of course monofilament and tuning fork tests are subjective, whereas neuropad®, on the other hand, is not a subjective test but is categorical.

But people with diabetes have an annual foot test, why should I be bothered about testing with neuropad®?

Good question.

According to the UK National Diabetes Audit (2010-11 and 2011-12), there remains significant national variation in the annual diabetes-related foot test. In fact for Type 1 diabetes the variation is from 47% in the lowest performing region to 87% in the best and from 73% – 90% for Type 2 patients.

Now let’s consider the accuracy of the most common subjective tests in mild, moderate and severe clinical neuropathy.

The 128MHz tuning fork? Well, that may misdiagnose 55% of the time, and monofilament may misdiagnose in 29% of people with diabetes. Fundamentally, misdiagnosing risk may result in considerable and unavoidable cost to our NHS and patients’ quality of life. 3

People with diabetes are at risk of developing a foot ulcer during their stay in hospital.

These risks can be reduced if their feet are examined during admission, and actions are taken to prevent ulcers from developing. In 2013, only 42 per cent of people had their feet examined at any point during their hospital stay. The same is also the case with care homes and the vulnerable elderly people they house. 4

neuropad®: 9 key benefits

Rapidly determines sudomotor dysfunction (anhydrosis) of the feet (10-15 minutes).

Has high sensitivity for the detection of diabetic autonomic neuropathy.10,11,12

Is useful for large-scale screening of at-risk patients with diabetes.

Identifies damage to C-nerve fibres. 3,11,13

Is a non-invasive and painless self-test for home and clinic use.

Is a categorical, non-subjective test with excellent reproducibility.14

Is simple to apply and easy to interpret results.5

In clinical trials, the sensitivity and specificity of neuropad® for diabetic neuropathy was comparable to that of well-established secondary-care diagnostic tests.

Time to complete the colour change was associated with the severity of the neuropathy.

Please click here to access usage instructions.

Precautions, warnings and product information

The neuropad® test is strictly for external use only. It should not be applied to any part of the body except to the sole of the foot. If the skin of the foot is badly cracked or if there are obvious fissures or open wounds or there are signs of local inflammation (red skin) do not apply the pad and contact a healthcare professional as soon as possible.

The pads must not come into contact with the eyes or any mucus membranes and must never be swallowed or inhaled. Do not use if you are allergic to chrome, nickel or cobalt.

Keep out of the reach of children.

Product composition

Substrate: transparent polyolefin film (medically modified).

Adhesive: hypoallergenic medical grade polyacrylate glue. Indicator pad: 100% viscose, binder reinforced, impregnated with CoCl2 solution. Legal classification: CE medical device Class I, Annex I + VII, Directive 93/42 EEC.

References

1. HSCIC: National Diabetes Audit 2011–2012: The Information Centre for Health and Social Care Hospital Episode Statistics 2007–8 to 2011–12.

2. Tentolouris N, Voulgari C, Liatis S, et al. Moisture status of the skin of the feet assessed by the visual test neuropad® correlates with foot ulceration in diabetes. Diabetes Care. 2010; 33(5):1112-14.

3. Perkins BA, Olaleye D, Zinman B, et al. Simple screening tests for peripheral neuropathy in the diabetes clinic. Diabetes Care 2001;24(2):250-6.

4. HSCIC (2014): National Diabetes Inpatient Audit. The Information Centre for Health and Social Care Hospital Episode Statistics 2013.