Sixty-five patients were enrolled (10–22 patients per site). Inclusion criteria included age 18–70 years, presence of diabetes mellitus, a sural nerve amplitude response of 1.0 µV or more and the presence of symmetrical distal DSP as defined by the modified San Antonio Criteria, in which two of symptoms, signs, abnormal nerve conduction parameters or abnormal vibration perception thresholds (VPT) were required [14 (link)]. Patients were stratified for disease severity on the basis of the TCNS in order to determine the performance of the mTCNS across the full range of disease severity [9 (link)]. Patients were excluded if they had known non-diabetic causes of neuropathy (for example, vitamin deficiencies, uraemia, thyroid disease, lumbar or cervical radiculopathy, inflammatory neuropathy or presence of alcoholism).
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