Search

UNLABELLED The new indicator test for sudomotor function (Neuropad) has been shown to represent a highly sensitive and reproducible tool for the diagnosis of diabetic peripheral neuropathy. This study aimed to examine the utility of the indicator test in the assessment of the staged severity of neuropathy in patients with type 2 diabetes mellitus. The study included 120 type 2 diabetic patients (58 men) with a mean age of 67.3+/-5.9 years and a mean diabetes duration of 13.1+/-3.2 years. Neuropathy was diagnosed and staged by clinical examination and nerve conduction study, according to the Michigan classification system. Patients were also examined with the indicator test, applied on the plantar aspect of the feet. Time until complete colour change of the test was recorded and stratified into deciles according to the spread of measurements in the study population. Neuropathy was staged as class 0 in 37 patients, class 1 in 44 patients, class 2 in 28 patients and class 3 in 11 patients. Time until complete colour change was 436.5+/-62.9, 740+/-88.1, 1192.5+/-161 and 1817.3+/-127.4 seconds in patients staged as class 0, 1, 2 and 3 respectively (p=0.001). Use of a threshold lower than 530 seconds until complete colour change had 97% sensitivity and 100% specificity for diagnosis of class 0 neuropathy. Use of a threshold lower than 1000 seconds until complete colour change had 100% sensitivity and 97% specificity for class 1 neuropathy. A threshold lower than 1440 seconds had 93% sensitivity and 100% specificity for class 2 neuropathy. A threshold above 1440 seconds had 100% sensitivity and 99% specificity for class 3 neuropathy. A highly significant (Kendall's tau-b=0.848, p=0.001) correlation was shown between time until complete colour change of the test and Michigan class of neuropathy. CONCLUSIONS It appears that the indicator test contributes substantially to the assessment of the staged severity of neuropathy in patients with type 2 diabetes mellitus. There is excellent agreement between the indicator test and the Michigan classification system. These results suggest a role for the indicator test in the assessment of diabetic neuropathy.

UNLABELLED Sudomotor neuropathy is associated with reduction of plantar sweating and contributes to the pathogenesis of diabetic foot ulcers. The aim of the present study was to evaluate the new indicator test for sudomotor function (Neuropad) in the diagnosis of peripheral neuropathy among type 2 diabetic patients. This study included 104 type 2 diabetic patients (51 men) with a mean age of 64.2+/-5.6 years and a mean diabetes duration of 12.8+/-3.7 years. Peripheral neuropathy was diagnosed by means of the Diabetic Neuropathy Index (DNI). Sudomotor neuropathy was assessed by means of colour change in the indicator test. Peripheral neuropathy was diagnosed in 71 patients (68.3 %). Sudomotor neuropathy was diagnosed in 67 patients (94.4 %) with peripheral neuropathy and in 10 patients (30.3 %) without peripheral neuropathy (p=0.0001). Compared with DNI, sensitivity of the indicator test for diagnosing peripheral neuropathy was 94.4 % and specificity was 69.7 %. Overall prevalence of neuropathy was higher using the indicator test (77 patients, 74.0 %) than using the DNI (71 patients, 68.3 %). Time until complete colour change of the indicator test was 23.8+/-6.7 min in patients with peripheral neuropathy and 7.7+/-1.2 min in patients without peripheral neuropathy (p=0.001). Among patients with peripheral neuropathy, time until complete colour change of the indicator test was 14.2+/-1.9 min in those with a DNI value between 2.5 and 4.5, while it was 32.8+/-2.6 min in those with a DNI value between 5 and 8 (p=0.003). CONCLUSIONS Use of the new indicator test has a very high sensitivity in detection of diabetic peripheral neuropathy. Sudomotor dysfunction can be demonstrated in a considerable part of patients with normal clinical examination. Time until complete colour change of the indicator test is associated with severity of peripheral neuropathy.