NEUROPAD® SUDOMOTOR DIAGNOSTIC TEST IN THE EARLY

DETECTION OF DIABETIC NEUROPATHY.

Dr. Nicolas Lorenzini; Dr. Claudio Diaz; E.U. Tamara Quintana.
María Latife Saadi Family Health Center, Corporación Municipal de Rancagua, Chile

INTRODUCTION RESULTS

In Chile, there are an estimated 1,372,700 people with Diabetes Mellitus,
which represents 11% of the population.
Approximately 15% to 25% of diabetics develop a foot ulcer throughout
their lives, which can evolve into a serious injury and amputation.
In Chile according to the 2017 public health sector hospital discharge
register, 67.9% of all lower extremity amputations are due to diabetic foot
ulcer (DFU).
OBJECTIVE
To evaluate the diagnostic capacity and efficacy of Neuropad, versus
traditional tests used in the detection of diabetic peripheral neuropathy
in primary health care patients.
The Gold Standard for the evaluation of DFN is electrodiagnostic studies
(sensory and motor electromyography) which are considered the most
sensitive tool for its detection. But this type of study is not available in
primary health care, due to its high cost.
In this study, when using MF as an instrument to determine DFN, 40% of
individuals with a positive result were found; while for the NEUROPAD®
test, there were 80% of positive results.
When NEUROPAD® was contrasted with the standard MF and MF
associated with a tuning fork of 128 Hz, the sensitivity was 93.2% and
specificity was 29.2%.
However, when calculating the proportion of false positives, we found
70.8% of cases in which the NEUROPAD® test remains positive, but the
MF detects as NPD-free.
The diagnostic validity of NEUROPAD® for the detection of peripheral
neuropathy has shown high sensitivity.
TABLE 1
NEUROPAD VERSUS MONOFILAMENT AND MONOFILAMENT-DIAPASON DIAGNOSTIC TESTS 128 HZ

S (%) CI (%) E (%) CI (%) PPV (%) NPV (%) FPP (%) FNP (%)

Neuropad
vs 93,6 71,7 a 98,9 29,2 14,9 a 49,2 46,9 87,5 70,8 6,3
MF

Neuropad
vs 93,8 71,7 a 98,9 29,2 14,9 a 49,2 46,9 87,5 70,8 6,3
Figura 1. 10 grams monofilament. Figura 2. Neuropad®. MF-Diapasón

Monofilament (MF), Confidence Interval (CI). Sensitivity (S), Specificity (S), Positive Predictive
METHODOLOGY
Value (PPV), Negative Predictive Value (NPV), False Positive Proportion (FPP) and False Negative

Cross-sectional study Proportion (FNP).

DISCUSSION
Random sampling Variables analyzed
Sex 24 males/16 females The most frequent causative component of DFU is Distal Peripheral
Age Mean 56.9 + 11.9 years Neuropathy (DPN). The main characteristic of DPN is that short nerve
Population
40 (n) Time of disease evolution 11.8 + 7.9 years fibers represent 70% - 90% of all peripheral nerve fibers, are the first to
History of ulcers/injuries be damaged by chronic hyperglycemia. They are responsible for thermal
16 ♀; 24
♂
Glycosylated hemoglobin 8,3 + 1,6 mg/dl sensation and pain, as well as autonomic functions such as sweating.
Presence of signs and symptoms of DFN

The current way of diagnosing DPN is based on damage to the long nerve
Inclusion criteria Exclusion criteria fibers.
Established diagnosis of DM2 Previous diagnosis Nephrotic Alcoholism
neuropathy syndrome
Age between 20 and 80 years The use of MF has been the traditional method for the diagnosis of DPN,
Current or previous
old Cirrhosis or chronic Renal disease chemotherapy although this instrument has limitations as it is operator dependent.
liver disease treatment
Be a regular patient under On the contrary, early evaluation in a simply and objectively with
control in the cardiovascular
health program of the "María
Vitamin B12 NEUROPAD® in patients with DM will favor an early diagnosis.
deficiency or Oncologic disease HIV
Latife Saadi" family health anemia
center of the district of
Rancagua. Uncontrolled
AMI in the last 6
Vasculitis diagnosis hypothyroidism or
months thyrotoxicosis CONCLUSION
Dehydration or Previous Enfermedad The diagnostic validity of NEUROPAD® for the detection of DPN lies in its
fever amputation vertebral
Patients who in control in the cardiovascular program have
high sensitivity.
evidenced some acute complication of DM
(hyper/hypoglycemia).
But it has low specificity, The reason for this is that small fiber
neuropathy is an early manifestation of diabetic neuropathy. The use of
NEUROPAD® consists of a qualitative diagnostic test, based on a visual
large fiber tests, such as vibration perception threshold and
indicator, which uses a color change to define the integrity of the
monofilament to define "neuropathy" will not detect patients with early
cholinergic sympathetic enervation of the skin (short C fibers), given by
neuropathy, which explains the low specificity of the Neuropad.
the sudomotor function.

The current way of diagnosing DPN is based on the damage of long

In the same patient, both diagnostic tests were performed with masking
nerve fibers but, as it has been demonstrated, this damage occurs later
for the investigators, one of whom performed the traditional evaluation
than the damage of short nerve fibers.
recommended by the technical orientation of diabetic foot management
of the Chilean Ministry of Health and another investigator applied the
It is advisable to consider NEUROPAD®, as an element of early diagnosis
NEUROPAD® diagnostic test. The information collected was analyzed by a
of DPN, as a screening tool to take timely preventive measures, to
third researcher in charge of the statistical analysis.
reduce and prevent injuries and future amputations.