ProMed, LLC
BioScan SudoCheck
Designed for Clinicians by Clinicians.
Solutions
BioScan SudoCheck System
In 3-5 Minutes Identify Patients At Risk:
Small nerve fibers are the very first victims of diabetes, which is known to affect the peripheral nervous system even symptoms remain sub-clinical. According to a recent study, already at an early stage of the diabetes evolution, the sympathetic innervation of eccrine sweat glands is progressively reduced. Irrespective of temperature and physical exercise, this alteration of the sweat glands’ autonomous control causes a longlasting shift in the ionic balance of sweat conducts.
* Small unmyelinated C-fibers are responsible for the function of sweat glands
* Sudomotor dysfunction has been established as one of the earliest detectable neurophysiologic abnormalities in distal small fiber neuropathies.
* A quantitative assessment of sweat response is an index of the severity and distribution of automatic failure. It will also serve as an early indicator for the regeneration of small fibers.
* Diabetic patients have been observed to experience a degeneration of small C-fiber innervating sweat glands.
* Measures bio electrochemical sweat skin conductances (BEC) are directly connected to the capability of the glands to transfer chloride ions and which reflects small-C fiber status.
* VitalScan SudoCheck is a fast and easy method to measure sweat function
* 3 minutes or 6 minutes test options.
* It does not require any patient preparation, such as blood drawing or fasting.
* Non-invasive and delivers immediate results, with findings within 3 minutes.
* It was developed for general practitioners, cardiologists, and neurologists to assist in the effective screening of cardiometabolic risk in patients.
* Evaluate patients with Diabetes Mellitus, as an instrument to assess autonomic neuropathy and neuropathic pain.
* Operates with a sensitivity of 80% and a specificity of 95%.
* Results suggest that the peripheral autonomic nervous system plays a role in painful diabetic neuropathy.
* Results correlated significantly with clinical neuropathy scores, pain scores and measures of autonomic dysfunction.
* Evaluate in patients with Diabetes Mellitusm, as an instrument to assess autonomic neuropathy and neuropathic pain.
* VitalScan SudoCheck is an innovative, sensitive tool for the detection of diabetic neuropathy, especially painful diabetic neuropathy. As sweat glands are innervated by small c fibers, which are also involved in pain pathways, precise measuring of the sweat gland function can identify that cause.
Why evaluate sudomotor function?
The study of sudomotor presents a valuable tool to assess autonomic disorders. Sudomotor function is known to reflect sympathetic activity and provide insight into postganglionic autonomic innervation.
Recent clinical studies have shown that the level of glycemia influenced conventional tests. VitalScan SudoCheck, however, has proven to be a reproducible and quantitative test method. In addition, VitalScan SudoCheck’s Bio Electrochemical Sweat Conductance (BEC) reflects sympathetic dependent sweat function.
The need for a faster sudomotor function test
Sudomotor function assessment can now be carried out faster and simpler with the new VitalScan SudoCheck technology.
In response to electrochemical activation, it measures the ability of sweat glands to release chloride ions and detects abnormalities. Once suspected or confirmed, more specialized tests are recommended to diagnose the underlying cause of the irregularity.
Evaluation of sudomotor function in diabetes
On of the significant causes of nerve damage is diabetes. Diabetic patients suffer from metabolic impairment and related inflammatory processes. As a result, their non-myelinated axons of small fiber nerves are primarily affected and known as Diabetic Autonomic Neuropathy (DAN).
There are presently several clinical studies ongoing to validate VitalScan SudoCheck’s new technology for DAN detection.
Small fiber nerves are early victims of diabetes
While symptoms remain sub-clinical, diabetes affects the peripheral nervous system, and small nerve fibers are usually the first victims. VitalScan SudoCheck was developed as a new device to follow up on complications related to diabetes.
Solutions
Precise Evaluations...
VitalScan SudoCheck has been created to enable a precise evaluation of sweat gland function. Based on a measuring method, patients place their hands and feet on stainless-steel electrodes. The method uses low voltage to stimulate the sweat glands and measure the electrochemical reaction between electrodes and chloride ions. This active, new method provides information and evidence of a sweat dysfunction that might otherwise not be detectable in physiological conditions. Bioelectrical Conductances (BEC, in micro siemens, uS) for the hands and feet express the quantitative results, while a risk score derives from demographic data and the BEC values.
The VitalScan SudoCheck system, in accordance with the 21 CFR 882.1540, represents a sympathetic skin response device that provides skin conductance measurements on a computer screen.
VitalScan SudoCheck is, similar to a galvanic skin response stress test, a functional test that measures the sweat glands’ capacity to release chloride ions following an electrochemical stimulation. It works by measuring the electrical potential difference caused by the electrochemical reaction of electrodes, which are applied to the skin and stimulated by a low voltage of variable amplitude. VitalScan SudoCheck comes with 4×2 independent electrodes for placement on feet or palms and other areas with a high number of sweat glands.
VitalScan SudoCheck provides information that determines the cardiometabolic risk in patients.
Solutions
SudoCheck Advantages
Analyze and test SudoCheck’s responsiveness and accuracy in detecting diabetic neuropathy and compare it with existing standardized tests for the diagnosis of diabetic neuropathy.
Evaluate SudoCheck in patients with Diabetes Mellitusm, as an instrument to assess autonomic neuropathy and neuropathic pain.
SudoCheck is an innovative, sensitive tool for the detection of diabetic neuropathy, especially painful diabetic neuropathy. As sweat glands are innervated by small c fibers, which are also involved in pain pathways, precise measuring of the sweat gland function can identify that cause.
SudoCheck, a sensitive device to detect neuropathy in patients with diabetes mellitus, operates with a high sensitivity and specificity.
When compared to non-painful neuropathy, feet BEC was significantly decreased in patients with painful diabetic neuropathy.
When compared to non-painful neuropathy, feet BEC was significantly decreased in patients with painful diabetic neuropathy.
Solutions
Intended Use Is to Diagnose:
For use by general practitioners, pharmacists, cardiologist, neurologist and pain medicine
To assist in the effective screening of cardiometabolic risk in patients
Painful, small fiber neuropathy when nerve conduction test results are normal
Disturbances of the autonomic nervous system which controls the sweat glands, heard, digestive system, other organs, and blood pressure
Complex pain disorders
Diabetic neuropathies
RSD (Reflex Sympathetic Dystrophy)
Dysautonomia
Pharmaceutical agents