Login Register Cart 0
Generic placeholder image

Current Vascular Pharmacology

Editor-in-Chief

ISSN (Print): 1570-1611
ISSN (Online): 1875-6212

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
General Research Article

Validation of Neuropad in the Assessment of Peripheral Diabetic Neuropathy in Patients with Diabetes Mellitus Versus the Michigan Neuropathy Screening Instrument, 10g Monofilament Application and Biothesiometer Measurement

Author(s): Ioanna Zografou, Fotios Iliadis, Christos Sambanis and Triantafyllos Didangelos*

Volume 18, Issue 5, 2020

Page: [517 - 522] Pages: 6

DOI: 10.2174/1570161117666190723155324

Price: $65

Abstract

Objective: Sudomotor dysfunction is a feature of Diabetic Peripheral Neuropathy (DPN). The indicator plaster Neuropad can provide an easy and accurate way to diagnose DPN. The aim of the present study was to evaluate Neuropad’s specificity, sensitivity and accuracy in detecting DPN in patients with Diabetes Mellitus (DM).

Methods: A total of 174 patients with DM (79 with type 1 DM, 88 women), mean age 49.8 ± 16.1 years and mean DM duration 17.3 ± 7.7 years were included in the present study. The following methods were used to diagnose DPN: the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE, respectively), application of 10 g monofilament (MONO) and measurement of vibration perception threshold with biothesiometer (BIO). Neuropad was applied to both feet in all patients and according to the presence or absence of color change of the sticker, patients were divided in two groups: group A (n = 82, complete change in color from blue to pink, depicting normal perspiration) and group B (n = 92, incomplete or no change, depicting abnormal perspiration).

Results: MNSIQ and MNSIE were positive for DPN in 111 and 119 patients, respectively. BIO was abnormal in 109 and MONO in 59 patients. Sensitivity of Neuropad testing was 95% vs. MONO, 73% vs. BIO, 73% vs. MNSIE and 75% vs. ΜNSIQ. Specificity was 69, 81, 90 and 92%, respectively and accuracy of the test was 78, 76, 78 and 83%, respectively.

Conclusion: Neuropad has a high sensitivity and specificity in detecting DPN vs. MNSIQ, MNSIE and BIO. Neuropad has a high sensitivity but moderate specificity vs. MONO. The accuracy of the test was high in all measurements.

Keywords: Diabetic peripheral neuropathy, neuropad, sensitivity, specificity, diabetes mellitus, vascular risk.

« Previous Next »
Graphical Abstract

[1]
Dyck PJ, Kratz KM, Karnes JL, et al. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester diabetic neuropathy study. Neurology 1993; 43(4): 817-24.
[http://dx.doi.org/10.1212/WNL.43.4.817] [PMID: 8469345]
[2]
Dyck PJ, Litchy WJ, Lehman KA, Hokanson JL, Low PA, O’Brien PC. Variables influencing neuropathic endpoints: the Rochester Diabetic neuropathy study of healthy subjects. Neurology 1995; 45(6): 1115-21.
[http://dx.doi.org/10.1212/WNL.45.6.1115] [PMID: 7783874]
[3]
Edwards JL, Vincent AM, Cheng HT, Feldman EL. Diabetic neuropathy: mechanisms to management. Pharmacol Ther 2008; 120(1): 1-34.
[http://dx.doi.org/10.1016/j.pharmthera.2008.05.005] [PMID: 18616962]
[4]
Humphrey LL, Palumbo PJ, Butters MA, et al. The contribution of non-insulin-dependent diabetes to lower-extremity amputation in the community. Arch Intern Med 1994; 154(8): 885-92.
[http://dx.doi.org/10.1001/archinte.1994.00420080085009] [PMID: 8154951]
[5]
Boulton AJM. The diabetic foot: from art to science. The 18th Camillo Golgi lecture. Diabetologia 2004; 47(8): 1343-53.
[http://dx.doi.org/10.1007/s00125-004-1463-y] [PMID: 15309286]
[6]
Quattrini C, Jeziorska M, Malik RA. Small fiber neuropathy in diabetes: clinical consequence and assessment. Int J Low Extrem Wounds 2004; 3(1): 16-21.
[http://dx.doi.org/10.1177/1534734603262483] [PMID: 15866784]
[7]
Rith-Najarian S, Branchaud C, Beaulieu O, Gohdes D, Simonson G, Mazze R. Reducing lower-extremity amputations due to diabetes. Application of the staged diabetes management approach in a primary care setting. J Fam Pract 1998; 47(2): 127-32.
[PMID: 9722800]
[8]
American Diabetes Association. Diabetes care: standards of medical care in diabetes. J Clin App Res Edu .2018 Available fromhttp://care.diabetesjournals.org/content/diacare/suppl/2017/12/08/41.Supplement_1.DC1/DC_41_S1_Combined.pdf
[9]
Papanas N, Ziegler D. New diagnostic tests for diabetic distal symmetric polyneuropathy. J Diabetes Complications 2011; 25(1): 44-51.
[http://dx.doi.org/10.1016/j.jdiacomp.2009.09.006] [PMID: 19896871]
[10]
Young JA. Cobalt(ii) chloride hexahydrate. J Chem Educ 2003; 80: 610.
[http://dx.doi.org/10.1021/ed080p610]
[11]
Quattrini C, Jeziorska M, Tavakoli M, Begum P, Boulton AJ, Malik RA. The Neuropad test: a visual indicator test for human diabetic neuropathy. Diabetologia 2008; 51(6): 1046-50.
[http://dx.doi.org/10.1007/s00125-008-0987-y] [PMID: 18368386]
[12]
Tentolouris N, Achtsidis V, Marinou K, Katsilambros N. Evaluation of the self-administered indicator plaster neuropad for the diagnosis of neuropathy in diabetes. Diabetes Care 2008; 31(2): 236-7.
[http://dx.doi.org/10.2337/dc07-1942] [PMID: 18025406]
[13]
Zick R, Schaper T, Deeters U. Early detection of peripheral neuropathy measurement of perspiration in the diabetic foot. Klinikarzt 2003; 32(8): 288-90.
[http://dx.doi.org/10.1055/s-2003-42191]
[14]
Bloom S, Till S, Sönksen P, Smith S. Use of a biothesiometer to measure individual vibration thresholds and their variation in 519 non-diabetic subjects. Br Med J (Clin Res Ed) 1984; 288(6433): 1793-5.
[http://dx.doi.org/10.1136/bmj.288.6433.1793] [PMID: 6428547]
[15]
Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA. A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care 1994; 17(11): 1281-9.
[http://dx.doi.org/10.2337/diacare.17.11.1281] [PMID: 7821168]
[16]
Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 1972; 18(6): 499-502.
[http://dx.doi.org/10.1093/clinchem/18.6.499] [PMID: 4337382]
[17]
https://www.kidney.org/content/ckd-epi-creatinine-equation-2009
[18]
Apelqvist J, Bakker K, van Houtum WH, Schaper NC. Practical guidelines on the management and prevention of the diabetic foot: based upon the International Consensus on the Diabetic Foot (2007) Prepared by the International Working Group on the Diabetic Foot. Diabetes Metab Res Rev 2008; 24(Suppl. 1): S181-7.
[http://dx.doi.org/10.1002/dmrr.848] [PMID: 18442189]
[19]
Daousi C, MacFarlane IA, Woodward A, Nurmikko TJ, Bundred PE, Benbow SJ. Chronic painful peripheral neuropathy in an urban community: a controlled comparison of people with and without diabetes. Diabet Med 2004; 21(9): 976-82.
[http://dx.doi.org/10.1111/j.1464-5491.2004.01271.x] [PMID: 15317601]
[20]
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): 1112-4.
[http://dx.doi.org/10.2337/dc09-2027] [PMID: 20150296]
[21]
Papanas N, Giassakis G, Papatheodorou K, et al. 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. J Diabetes Complications 2007; 21(6): 353-8.
[http://dx.doi.org/10.1016/j.jdiacomp.2006.08.003] [PMID: 17967706]
[22]
Yoshioka K, Okada H. Useful application of the Neuropad test for assessment of diabetic polyneuropathy. Intern Med 2012; 51(23): 3241-5.
[http://dx.doi.org/10.2169/internalmedicine.51.8366] [PMID: 23207118]
[23]
Papanas N, Boulton AJ, Malik RA, et al. A simple new non-invasive sweat indicator test for the diagnosis of diabetic neuropathy. Diabet Med 2013; 30(5): 525-34.
[http://dx.doi.org/10.1111/dme.12000] [PMID: 22924579]
[24]
Papanas N, Paschos P, Papazoglou D, et al. Accuracy of the neuropad test for the diagnosis of distal symmetric polyneuropathy in type 2 diabetes. Diabetes Care 2011; 34(6): 1378-82.
[http://dx.doi.org/10.2337/dc10-2205] [PMID: 21505209]
[25]
Papanas N, Papatheodorou K, Papazoglou D, Kotsiou S, Maltezos E. A prospective study on the use of the indicator test Neuropad® for the early diagnosis of peripheral neuropathy in type 2 diabetes. Exp Clin Endocrinol Diabetes 2011; 119(2): 122-5.
[http://dx.doi.org/10.1055/s-0030-1261934] [PMID: 20690070]
[26]
Ziegler D, Papanas N, Rathmann W, Heier M, Scheer M, Meisinger C. KORA Study Group. Evaluation of the Neuropad sudomotor function test as a screening tool for polyneuropathy in the elderly population with diabetes and pre-diabetes: the KORA F4 survey. Diabetes Metab Res Rev 2012; 28(8): 692-7.
[http://dx.doi.org/10.1002/dmrr.2340] [PMID: 22949335]
[27]
Papanas N, Papatheodorou K, Papazoglou D, Monastiriotis C, Christakidis D, Maltezos E. A comparison of the new indicator test for sudomotor function (Neuropad) with the vibration perception threshold and the clinical examination in the diagnosis of peripheral neuropathy in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes 2008; 116(2): 135-8.
[http://dx.doi.org/10.1055/s-2007-984455] [PMID: 18095233]
[28]
Tsapas A, Liakos A, Paschos P, et al. A simple plaster for screening for diabetic neuropathy: a diagnostic test accuracy systematic review and meta-analysis. Metabolism 2014; 63(4): 584-92.
[http://dx.doi.org/10.1016/j.metabol.2013.11.019] [PMID: 24405753]
[29]
Manes C, Papanas N, Exiara T, et al. The indicator test Neuropad in the assessment of small and overall nerve fibre dysfunction in patients with type 2 diabetes: a large multicentre study. Exp Clin Endocrinol Diabetes 2014; 122(3): 195-9.
[http://dx.doi.org/10.1055/s-0034-1367061] [PMID: 24643697]
[30]
Mendivil CO, Kattah W, Orduz A, Tique C, Cárdenas JL, Patiño JE. Neuropad for the detection of cardiovascular autonomic neuropathy in patients with type 2 diabetes. J Diabetes Complications 2016; 30(1): 93-8.
[http://dx.doi.org/10.1016/j.jdiacomp.2015.10.004] [PMID: 26525688]
[31]
Ponirakis G, Fadavi H, Petropoulos IN, et al. Automated quantification of neuropad improves its diagnostic ability in patients with diabetic neuropathy. J Diabetes Res 2015; 2015847854
[http://dx.doi.org/10.1155/2015/847854] [PMID: 26064991]
[32]
Lazzarini PA, Hurn SE, Fernando ME, et al. Prevalence of foot disease and risk factors in general inpatient populations: a systematic review and meta-analysis. BMJ Open 2015; 5(11) e008544
[http://dx.doi.org/10.1136/bmjopen-2015-008544] [PMID: 26597864]
[33]
Brownrigg JR, Schaper NC, Hinchliffe RJ. Diagnosis and assessment of peripheral arterial disease in the diabetic foot. Diabet Med 2015; 32(6): 738-47.
[http://dx.doi.org/10.1111/dme.12749] [PMID: 25764390]
[34]
Forsythe RO, Brownrigg J, Hinchliffe RJ. Peripheral arterial disease and revascularization of the diabetic foot. Diabetes Obes Metab 2015; 17(5): 435-44.
[http://dx.doi.org/10.1111/dom.12422] [PMID: 25469642]
[35]
Antonoglou C, Papanas N, Maltezos E. Lipid-lowering therapy in the diabetic foot: seeing the whole iceberg and not just the tip. Curr Vasc Pharmacol 2014; 12(5): 745-50.
[http://dx.doi.org/10.2174/15701611113119990127] [PMID: 23016899]
[36]
Dietrich I, Braga GA, de Melo FG, da Costa Silva Silva ACC. The diabetic foot as a proxy for cardiovascular events and mortality review. Curr Atheroscler Rep 2017; 19(11): 44.
[http://dx.doi.org/10.1007/s11883-017-0680-z] [PMID: 28971322]
[37]
Papanas N, Ziegler D. Risk factors and comorbidities in diabetic neuropathy: an update. Rev Diabet Stud 2015; 12(1-2): 48-62.
[http://dx.doi.org/10.1900/RDS.2015.12.48] [PMID: 26676661]
[38]
Brownrigg JR, de Lusignan S, McGovern A, et al. Peripheral neuropathy and the risk of cardiovascular events in type 2 diabetes mellitus. Heart 2014; 100(23): 1837-43.
[http://dx.doi.org/10.1136/heartjnl-2014-305657] [PMID: 25095826]
[39]
Brownrigg JR, Davey J, Holt PJ, et al. The association of ulceration of the foot with cardiovascular and all-cause mortality in patients with diabetes: a meta-analysis. Diabetologia 2012; 55(11): 2906-12.
[http://dx.doi.org/10.1007/s00125-012-2673-3] [PMID: 22890823]
[40]
Bajaj S, Mahajan A, Grover S, Mahajan V, Goyal P, Gupta VK. Peripheral vascular disease in patients with diabetic foot ulcers - an emerging trend: a prospective study from north India. J Assoc Physicians India 2017; 65(5): 14-7.
[PMID: 28598042]
[41]
Unmar Y, Zafar MI, Gao F. Factors associated with peripheral neuropathy in type 2 diabetes: Subclinical versus confirmed neuropathy. J Huazhong Univ Sci Technolog Med Sci 2017; 37(3): 337-42.
[http://dx.doi.org/10.1007/s11596-017-1737-5] [PMID: 28585130]
[42]
Tuttolomondo A, Maida C, Pinto A. Diabetic foot syndrome as a possible cardiovascular marker in diabetic patients. J Diabetes Res 2015; 2015 268390
[http://dx.doi.org/10.1155/2015/268390] [PMID: 25883983]
[43]
Katsiki N, Theocharidou E, Karagiannis A, Athyros VG, Mikhailidis DP. Ezetimibe therapy for dyslipidemia: an update. Curr Pharm Des 2013; 19(17): 3107-14.
[http://dx.doi.org/10.2174/13816128113199990314] [PMID: 23317398]
[44]
Sarigianni M, Katsiki N, Mikhailidis DP. Ezetimibe in diabetes: more than cholesterol lowering? Curr Med Res Opin 2010; 26(10): 2517-20.
[http://dx.doi.org/10.1185/03007995.2010.518519] [PMID: 20843163]
[45]
Perez-Matos MC, Morales-Alvarez MC, Mendivil CO. lipids: a suitable therapeutic target in diabetic neuropathy? J Diabetes Res 2017; 2017 6943851
[http://dx.doi.org/10.1155/2017/6943851] [PMID: 28191471]
[46]
Katsiki N, Athyros VG, Karagiannis A, Mikhailidis DP. The role of statins in the treatment of type 2 diabetes mellitus: an update. Curr Pharm Des 2014; 20(22): 3665-74.
[http://dx.doi.org/10.2174/13816128113196660673] [PMID: 24040875]
[47]
Adeghate J, Nurulain S, Tekes K, Fehér E, Kalász H, Adeghate E. Novel biological therapies for the treatment of diabetic foot ulcers. Expert Opin Biol Ther 2017; 17(8): 979-87.
[http://dx.doi.org/10.1080/14712598.2017.1333596] [PMID: 28532226]
[48]
Katsiki N, Nikolic D, Montalto G, Banach M, Mikhailidis DP, Rizzo M. The role of fibrate treatment in dyslipidemia: an overview. Curr Pharm Des 2013; 19(17): 3124-31.
[http://dx.doi.org/10.2174/1381612811319170020] [PMID: 23317397]
[49]
Katsiki N, Purrello F, Tsioufis C, Mikhailidis DP. Cardiovascular disease prevention strategies for type 2 diabetes mellitus. Expert Opin Pharmacother 2017; 18(12): 1243-60.
[http://dx.doi.org/10.1080/14656566.2017.1351946] [PMID: 28685623]
[50]
Katsiki N, Tentolouris N, Mikhailidis DP. Dyslipidaemia in type 2 diabetes mellitus: bad for the heart. Curr Opin Cardiol 2017; 32(4): 422-9.
[http://dx.doi.org/10.1097/HCO.0000000000000407] [PMID: 28362666]
[51]
Abouhamda A, Alturkstani M, Jan Y. Lower sensitivity of ankle-brachial index measurements among people suffering with diabetes-associated vascular disorders: A systematic review. SAGE Open Med 2019; 7 2050312119835038
[http://dx.doi.org/10.1177/2050312119835038] [PMID: 30854203]
[52]
Gómez-Banoy N, Cuevas V, Soler F, Pineda MF, Mockus I. Screening tests for distal symmetrical polyneuropathy in Latin American patients with type 2 diabetes mellitus. Arch Endocrinol Metab 2017; 61(5): 470-5.
[http://dx.doi.org/10.1590/2359-3997000000283] [PMID: 28724059]
[53]
Spallone V, Morganti R, Siampli M, et al. Neuropad as a diagnostic tool for diabetic autonomic and sensorimotor neuropathy. Diabet Med 2009; 26(7): 686-92.
[http://dx.doi.org/10.1111/j.1464-5491.2009.02760.x] [PMID: 19573117]
[54]
Ponirakis G, Petropoulos IN, Fadavi H, et al. The diagnostic accuracy of Neuropad for assessing large and small fibre diabetic neuropathy. Diabet Med 2014; 31(12): 1673-80.
[http://dx.doi.org/10.1111/dme.12536] [PMID: 24975286]

Rights & Permissions Print Cite
Article Metrics
26
© 2024 Bentham Science Publishers | Privacy Policy