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

Abstract

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^®) 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.

Diabetes mellitus - diabetic foot - diabetic neuropathy - sudomotor function

References

• 1 Abbott CA, Vileikyte L, Williamson S, Carrington AL, Boulton AJ. Multicenter study of the incidence of and predictive risk factors for diabetic neuropathic foot ulceration.  Diabetes Care. 1998;  21 1071-1075
• 2 Abbott CA, Carrington AL, Ashe H, Bath S, Every LC, Griffiths J. et al . The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort.  Diabet Med. 2002;  19 377-384
• 3 Armstrong DG, Lavery LA, Vela SA, Quebedeaux TL, Fleischli JG. Choosing a practical screening instrument to identify patients at risk for diabetic foot ulceration.  Arch Intern Med. 1998;  158 289-292
• 4 Boulton AJM, Kirsner RS, Vileikyte L. Neuropathic diabetic foot ulcers.  N Engl J Med. 2004;  351 48-55
• 5 Boulton AJ, Vinik AI, Arezzo JC, Bril V, Feldman EL, Freeman R, Malik RA, Maser RE, Sosenko JM, Ziegler D. American Diabetes Association . Diabetic neuropathies: a statement by the American Diabetes Association.  Diabetes Care. 2005;  28 956-962
• 6 Braune HJ, Horter C. Sympathetic skin response in diabetic neuropathy: a prospective clinical and neurophysiological trial on 100 patients.  J Neurol Sci. 1996;  138 120-124
• 7 Bril V, Perkins BA. Comparison of vibration perception thresholds obtained with the Neurothesiometer and the CASE IV and relationship to nerve conduction studies.  Diabet Med. 2002;  19 661-666
• 8 Davis EA, Jones TW, Walsh P, Byrne GC. The use of biothesiometry to detect neuropathy in children and adolescents with IDDM.  Diabetes Care. 1997;  20 1448-1453
• 9 Edmonds ME. The diabetic foot, 2003.  Diabetes Metab Res Rev. 2004;  20 (Suppl 1) S9-S12
• 10 Haslbeck KM, Schleicher E, Bierhaus A, Nawroth P, Haslbeck M, Neundörfer B. et al . The AGE/RAGE/NF-(kappa) B pathway may contribute to the pathogenesis of polyneuropathy in impaired glucose tolerance (IGT).  Exp Clin Endocrinol Diabetes. 2005;  113 288-291
• 11 Jurado J, Ybarra J, Pou JM. Isolated use of vibration perception thresholds and Semmes Weinstein monofilament in diagnosing diabetic polyneuropathy: “the North Catalonia diabetes study”.  Nurs Clin North Am. 2007;  42 59-66
• 12 Kumar S, Fernando DJ, Veves A, Knowles EA, Young MJ, Boulton AJ. Semmes-Weinstein monofilaments: a simple, effective and inexpensive screening device for identifying diabetic patients at risk of foot ulceration.  Diabetes Res Clin Pract. 1991;  13 63-67
• 13 Manes C, Mikoudi K, Sossidou E, Pigas G, Karagianni D, Skoutas D, Fotiadis S. Evaluation of a new indicator plaster in identifying diabetic patients at risk of foot ulceration.  Diabetologia. 2004;  47 ((Suppl 1)) A376
• 14 Marinou K, Maggana S, Liatis S, Nikolopoulos A, Diakoumopoulou E, Tentolouris N. et al . Usefulness of the indicator plaster Neuropad for the diagnosis of peripheral and autonomic neuropathy in patients with diabetes mellitus.  Diabetologia. 2005;  48 ((Suppl 1)) A995
• 15 Paisley AN, Abbott CA, van Schie CH, Boulton AJ. A comparison of the Neuropen against standard quantitative sensory-threshold measures for assessing peripheral nerve function.  Diabet Med. 2002;  19 400-405
• 16 Papanas N, Papatheodorou K, Christakidis D, Papazoglou D, Giassakis G, Piperidou H. et al . Evaluation of a new indicator test for sudomotor function (Neuropad) in the diagnosis of peripheral neuropathy in type 2 diabetic patients.  Exp Clin Endocrinol Diabetes. 2005;  113 195-198
• 17 Papanas N, Papatheodorou K, Papazoglou D, Christakidis D, Monastiriotis C, Maltezos E. Reproducibility of the new indicator test for sudomotor function (Neuropad) in patients with type 2 diabetes mellitus: short communication.  Exp Clin Endocrinol Diabetes. 2005b;  113 577-581
• 18 Papanas N, Gries A, Maltezos E, Zick R. The steel ball-bearing test: a new test for evaluating protective sensation in the diabetic foot.  Diabetologia. 2006;  49 739-743
• 19 Papanas N, Giassakis G, Papatheodorou K, Papazoglou D, Monastiriotis C, Christakidis D. et al . Use of the new indicator test (Neuropad) for the assessment of the staged severity of neuropathy in type 2 diabetic patients.  Exp Clin Endocrinol Diabetes. 2007;  115 58-61
• 20 Papanas N, Papatheodorou K, Papazoglou D, Christakidis D, Monastiriotis C, Maltezos E. The new indicator test (Neuropad): a valuable diagnostic tool for small-fiber impairment in patients with type 2 diabetes.  Diabetes Educ. 2007b;  33 257-258 , 260, 262 passim.
• 21 Papanas N, Papatheodorou K, Papazoglou D, Kotsiou S, Christakidis D, Maltezos E. An insertion/deletion polymorphism in the alpha2b adrenoceptor gene is associated with peripheral neuropathy in patients with type 2 diabetes mellitus.  Exp Clin Endocrinol Diabetes. 2007c;  115 327-330
• 22 Pham H, Armstrong DG, Harvey C, Harkless LB, Giurini JM, Veves A. Screening techniques to identify people at high risk for diabetic foot ulceration: a prospective multicenter trial.  Diabetes Care. 2000;  23 606-611
• 23 Rith-Najarian SJ, Stolusky T, Gohdes DM. Identifying diabetic patients at high risk for lower-extremity amputation in a primary health care setting. A prospective evaluation of simple screening criteria.  Diabetes Care. 1992;  15 1386-1389
• 24 Shimada H, Kihara M, Kosaka S, Ikeda H, Kawabata K, Tsutada T. et al . Comparison of SSR and QSART in early diabetic neuropathy: value of length-dependent pattern in QSART.  Auton Neurosci. 2001;  92 72-75
• 25 Veves A, Manes C, Murray HJ, Young MJ, Boulton AJ. Painful neuropathy and foot ulceration in diabetic patients.  Diabetes Care. 1993;  16 1187-1189
• 26 Vileikyte L, Hutchings G, Hollis S, Boulton AJ. The tactile circumferential discriminator. A new, simple screening device to identify diabetic patients at risk of foot ulceration.  Diabetes Care. 1997;  20 623-626
• 27 Young MJ, Boulton AJ, MacLeod AF, Williams DR, Sonksen PH. A multicentre study of the prevalence of diabetic peripheral neuropathy in the United Kingdom hospital clinic population.  Diabetologia. 1993;  36 150-154
• 28 Young MJ, Breddy JL, Veves A, Boulton AJ. The prediction of diabetic neuropathic foot ulceration using vibration perception thresholds. A prospective study.  Diabetes Care. 1994;  17 557-560
• 29 Zick R, Schäper T, Deeters U. Periphere diabetische Neuropathie. Die Schweißsekretion am Fuß messen.  Klinikarzt. 2003;  32 192-194
• 30 Zimny S, Pfohl M. Healing times and prediction of wound healing in neuropathic diabetic foot ulcers: a prospective study.  Exp Clin Endocrinol Diabetes. 2005;  113 90-93

Correspondence