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Usefulness of a new indicator test for the diagnosis of peripheral and autonomic neuropathy in patients with diabetes mellitus.
Liatis S, Marinou K, Tentolouris N, Pagoni S, Katsilambros N. Diabet Med. 2007 Oct 17
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Aims The aim of the present study was to assess the performance of a new indicator test (NIT), based on the measurement of sweat production after exposure to dermal foot perspiration, in the diagnosis of both peripheral sensorimotor polyneuropathy (PSN) and autonomic neuropathy in patients with diabetes.
Methods One hundred and seventeen diabetic patients were examined. PSN was assessed using the neuropathy symptoms score, the neuropathy disability score and the vibration perception threshold. Cardiac autonomic neuropathy (CAN) was assessed using the battery of the four classical standardized tests proposed by Ewing et al., Diabetes Care 1985; 8: 491-498. Sudomotor dysfunction was assessed using the NIT.
Results Fifty patients (42.7%) had PSN and 44 patients (37.6%) had CAN. Of the 50 patients with PSN, 43 had a positive NIT (sensitivity 86%) and, out of the 67 patients without PSN, a negative NIT was obtained in 45 patients (specificity 67%). The positive and the negative predictive value of the NIT in detecting PSN were 66.2 and 86.5%, respectively. The sensitivity and specificity of NIT in detecting CAN was 59.1 and 46.5%, respectively. In the case of severe CAN, the sensitivity was increased to 80.9% and the specificity to 50%.
Conclusions The NIT has good sensitivity and negative predictive value for diagnosis of PSN and can be used as a screening method for detection of this complication in patients with diabetes. In addition, the test has a low sensitivity for detection of autonomic neuropathy in patients with milder forms of CAN.
Neuropad for diagnosis of diabetic peripheral neuropathy
Sensitivity and specificity of a new indicator test (Neuropad) for the diagnosis of peripheral neuropathy in type 2 diabetes patients: a comparison with clinical examination and nerve conduction study.
Papanas N, Giassakis G, Papatheodorou K, Papazoglou D, Monastiriotis C, Christakidis D, Piperidou H, Maltezos E. J Diabetes Complications. 2007 Nov-Dec;21(6):353-8.
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OBJECTIVE: The objective of this study was to evaluate the sensitivity and specificity of a new indicator test (Neuropad) for the diagnosis of peripheral neuropathy in type 2 diabetes patients as compared with clinical examination and nerve conduction study (NCS).
PATIENTS AND METHODS: This study included 120 type 2 diabetes patients (58 men) with a mean age of 67.3+/-5.9 years and a mean diabetes duration of 13.1+/-3.2 years. Diabetic neuropathy was diagnosed through the Neuropathy Disability Score. An NCS was performed on radial, ulnar, sural, and common and deep peroneal nerves. Patients were also examined with the new indicator test. The "time to complete color change of the test" from blue to pink was recorded. The test was considered abnormal in patients who exhibited a time to complete color change of the test exceeding 600 s in at least one foot.
RESULTS: Neuropathy was diagnosed by clinical examination in 83 (69.2%) patients. The sensitivity of the indicator test for clinical neuropathy was 95.2%, and its specificity was 67.6%. The sensitivity of NCS for clinical neuropathy was 94%, and its specificity was 62.1%. The sensitivity of the indicator test for abnormal NCS was 97.8%, and its specificity was 96.4%.
CONCLUSIONS: The new indicator test has a very high sensitivity not only for the diagnosis of clinical neuropathy but also for the diagnosis of neurophysiological neuropathy. Specificity is moderately high for the diagnosis of clinical neuropathy, while it is particularly high for the diagnosis of neurophysiological neuropathy. The indicator test has a validity comparable to that of NCS for the diagnosis of diabetic neuropathy. Finally, the time to complete color change of the test is associated with the severity of nerve conduction impairment.
neuropad® - Early detection test for diabetic foot syndrome
neuropad® is a unique dressing that by colour change, indicates the hydro status of the foot and therefore the potential for developing DFS. The function of the perspiratory glands is vital for the elasticity and healthy function of the foot bed. The malfunction of these glands is the primary indication of the potential development of DFS and can now be detected before clinical symptoms occur.
The early prediction of DFS therefore allows adoption of effective prophylactic treatment. The effectiveness of neuropad® has been documented by clinical studies.
neuropad® is simple to use and is therefore attractive for the clinician who, for the first time, is able to screen for potential DFS and for the patient who can monitor, by self observation, their current DFS risk. This important stage of diabetes management is necessary as healthy feet are essential for continued mobility and physical activity, both of which contribute to a balanced carbohydrate level.
neuropad® is applied as an adhesive plaster and is positioned as illustrated. Within a few minutes the neuropad® will change colour from blue to pink and indicate a healthy condition or, if no colour change or only partial colour change, indicate a potential for DFS that requires further investigation and possible treatment.
Re: Sweat production and diagnosis of peripheral neuropathy
A Comparison of the New Indicator Test for Sudomotor Function (Neuropad(R)) with the Vibration Perception Threshold and the Clinical Examination in the Diagnosis of Peripheral Neuropathy in Subjects with Type 2 Diabetes.
Papanas N, Papatheodorou K, Papazoglou D, Monastiriotis C, Christakidis D, Maltezos E. Exp Clin Endocrinol Diabetes. 2007 Dec 20 [Epub ahead of print]
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Peripheral neuropathy remains a major cause of morbidity and is a cardinal factor in the pathogenesis of diabetic foot ulceration. The aim of the present study was to compare the new indicator test for sudomotor function (Neuropad ((R))) with the vibration perception threshold (VPT) and the clinical examination in the diagnosis of peripheral neuropathy in subjects with type 2 diabetes. This study included 154 type 2 diabetic patients (76 men) with a mean age of 64.3+/-7.3 years and a mean diabetes duration of 12.8+/-4.3 years. Neuropathy was diagnosed clinically using the Neuropathy Disability Score (NDS). The VPT was measured with a neurothesiometer, values25Volts being classified as abnormal. Sudomotor function was evaluated by the indicator test. Sensitivity of the indicator test for neuropathy was 97.8% and specificity was 67.2%. Sensitivity and specificity of VPT for neuropathy were 78.9% and 85.9% respectively. A significant correlation was shown between time to colour change of the indicator test and VPT (r (s)=0.889, p<0.001). CONCLUSIONS: Both the indicator test and the VPT have a high sensitivity for neuropathy. Sensitivity is higher with the indicator test, but specificity is higher with VPT. Time until complete colour change of the indicator test shows a positive correlation with VPT. Thus, the indicator test appears to be a useful additional diagnostic tool of neuropathy, particularly suitable for screening and self-examination, in type 2 diabetes. The correlation between time to colour change of the indicator test and VPT is interesting and merits investigation in a prospective study
Re: Sweat production and diagnosis of peripheral neuropathy
Evaluation of the self-administered indicator plaster neuropad for the diagnosis of neuropathy in diabetes.
Tentolouris N, Achtsidis V, Marinou K, Katsilambros N. Diabetes Care. 2008 Feb;31(2):236-7.
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OBJECTIVE: To evaluate the inter-rater reliability between patient and health care provider of the indicator plaster neuropad (IPN) in the diagnosis of peripheral neuropathy and the feasibility of the IPN.
RESEARCH DESIGN AND METHODS: A total of 156 patients with diabetes were examined. At the same visit, the IPN was evaluated by the health care provider. Afterward, the IPN with written instructions for its use and evaluation for self-testing at home were provided together with a questionnaire asking for the easiness of the IPN.
RESULTS: Neuropathy was diagnosed in 56.9% of the participants by the health care provider. The k statistic to measure overall agreement between patient and health care provider of the IPN was very good: 0.88 (95% CI 0.85-0.91). The indicated instructions and the IPN were evaluated as easy by the patients.
CONCLUSIONS: The high degree of reliability and the easiness of the IPN suggest that it is proper for self-testing for the identification of peripheral neuropathy.
Re: Sweat production and diagnosis of peripheral neuropathy
The Neuropad test: a visual indicator test for human diabetic neuropathy.
Quattrini C, Jeziorska M, Tavakoli M, Begum P, Boulton AJ, Malik RA. Diabetologia. 2008 Mar 27 [Epub ahead of print]
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AIMS/HYPOTHESIS: The commercially available Neuropad test was developed as a simple visual indicator test to evaluate diabetic neuropathy. It uses a colour change to define the integrity of skin sympathetic cholinergic innervation. We compared the results of Neuropad assessment in the foot with established measures of somatic and autonomic neuropathy.
METHODS: Fifty-seven diabetic patients underwent Neuropad assessment, quantitative sensory and autonomic function testing, and evaluation of intra-epidermal nerve fibre density in foot skin biopsies.
RESULTS: Neuropad responses correlated with the neuropathy disability score (r (s) = 0.450, p < 0.001), neuropathic symptom score (r (s) = 0.288, p = 0.03), cold detection threshold (r (s) = 0.394, p = 0.003), heat-as-pain perception threshold visual analogue score 0.5 (r (s) = 0.279, p = 0.043) and deep-breathing heart rate variability (r (s) = -0.525, p < 0.001). Intra-epidermal nerve fibre density (fibres/mm) compared with age- and sex-matched control subjects (11.06 +/- 0.82) was non-significantly reduced (7.37 +/- 0.93) in diabetic patients with a normal Neuropad response and significantly reduced in patients with a patchy (5.01 +/- 0.93) or absent (5.02 +/- 0.77) response (p = 0.02). The sensitivity of an abnormal Neuropad response in detecting clinical neuropathy (neuropathy disability score >/=5) was 85% (negative predictive value 71%) and the specificity was 45% (positive predictive value 69%).
CONCLUSIONS/INTERPRETATION: The Neuropad test may be a simple indicator for screening patients with diabetic neuropathy.
Re: Sweat production and diagnosis of peripheral neuropathy
Press release: Ark secures reimbursement for Neuropad® from UK NHS Business Services Authority
Ark Therapeutics
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London, UK, 2nd October 2008 - Ark Therapeutics Group plc (“Ark” or the “Company”) today announces that it has successfully achieved reimbursement from the UK NHS Business Services Authority for Neuropad®, an innovative diagnostic test to detect early stage peripheral autonomic neuropathy in the feet of diabetic patients. Neuropad® is the first product in a new diagnostic class to be available to the NHS on prescription.
Neuropad® will be promoted to the primary care community from 1 November 2008 after its listing in the Drug Tariff at a price of £6.99. Ark will market Neuropad® through its existing UK salesforce which currently markets the Company’s wound care products, Kerraboot®, Kerraped® and Flaminal®.
Diabetic foot syndrome frequently results in foot ulcers which are both distressing for the patient and difficult to treat as well as being a significant financial burden to the NHS. Neuropad® assesses the status of the sweat gland (sudomotor) response by measuring the moisture status of the foot. An abnormal sweat gland response is closely correlated with the onset of peripheral autonomic neuropathy in the feet.
Current screening tools for the early detection of the diabetic foot syndrome in primary care require a subjective patient response and rely on the skill of healthcare professionals. However, autonomic neuropathy affects small fibres much earlier in the disease process (in most cases) and Neuropad®, unlike the currently available tests in primary care, will detect this damage when patients are asymptomatic of large fibre damage.
Neuropad® has been designed to be safe, non-invasive and easily applied in a primary care setting, including long term residential or nursing care, and can be applied without additional training by practice nurses and community podiatrists as they perform routine screening of their diabetic patients. Neuropad® supports the NHS Quality Outcomes Framework which recommends that all diabetic patients are assessed for peripheral neuropathy every 15 months.
Early identification of neuropathy using Neuropad® will reduce the incidence of diabetic foot ulcers by allowing timely preventative measures to be implemented. The cost to the NHS of treating a foot ulcer is estimated to be £5,200 and as many as 64,000 diabetic patients are likely to develop an open ulcer in any one year1.
Commenting on today's announcement, Cecile Miles, Ark's Commercial Director, said: “This is very good news for our growing wound care business. Since Neuropad® is very sensitive and able to detect early neuropathy, we believe it will have a significant impact on the quality of diabetic foot screening available to patients, reducing both patient suffering and the clinical and cost burden of diabetic ulcers to the NHS.”
Dr Nigel Parker, CEO of Ark, added: “The process of securing reimbursement is taking an increasingly long time and we are very pleased to have got this through. Neuropad® is an ideal fit with Ark’s wound care strategy of introducing innovative products that deliver both clinical benefits and savings to the healthcare system. This news is in line with our plan to launch at least two new products during this year.”
Diabetes mellitus can result in damage to the nerves supplying the feet. Various tests can be used to assess nerve damage but no tests so far have been used to assess loss of sweating which can lead to dry skin, fissuring and ulceration. The indicator test (Neuropad) is a plaster which is applied to the sole of the feet just below the 1st and 2nd toes of both feet. If the color of the plaster changes to pink it indicates that there is no nerve damage to the nerves. However if the plaster retains the blue color or the color only partially changes to pink after 600 seconds then this is a positive test and the patient has nerve damage.
Re: Sweat production and diagnosis of peripheral neuropathy
Neuropad as a diagnostic tool for diabetic autonomic and sensorimotor neuropathy
V. Spallone, R. Morganti, M. Siampli, T. Fedele, C. D'Amato, L. Cacciotti and M. R. Maiello Diabetic Medicine Volume 26 Issue 7, Pages 686 - 692
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Aims The aim of the present study was to determine the diagnostic accuracy of the Neuropad sudomotor test for diabetic cardiovascular autonomic neuropathy (CAN) and diabetic polyneuropathy (DPN), the latter assessed using a multi-level diagnostic approach.
Methods In 51 diabetic patients, CAN, symptoms and signs of DPN, vibration perception threshold (VPT), cold (CTT) and warm thermal perception thresholds (WTT) were measured. Neuropad response was determined as normal (complete colour change) or abnormal (absent or incomplete colour change). The time until the complete colour change (CCC time) was recorded.
Results CCC time showed significant correlations with all the neurological parameters, the strongest of which were with Valsalva ratio (ρ = −0.64, P < 0.0001), symptoms of DPN (ρ = 0.66, P < 0.0001), postural hypotension (ρ = 0.54, P = 0.0001) and CTT (ρ = −0.54, P = 0.0001). CCC time showed moderate diagnostic accuracy for both CAN and DPN: the areas under the receiver operating characteristic (ROC) curves were 0.71 and 0.76, respectively. The diagnostic characteristics of three cut-off values of CCC time, identified by ROC analysis (i.e. 10, 15 and 18 min), were analysed. Compared with 10 min, the 15-min cut-off value provided better specificity (from 27% to 52% and from 31% to 62% for CAN and DPN, respectively) and a better likelihood ratio for negative result (from 0.67 to 0.34 and from 0.58 to 0.33) without lowering sensitivity (from 82% to 82% and from 85% to 80%).
Conclusions Neuropad is a reliable diagnostic tool for both CAN and DPN, albeit of only moderate accuracy. Extending the observation period to 15 min provides greater diagnostic usefulness.
Sweat production and diagnosis of peripheral neuropathy
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