CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 147 enrolled
Drug / intervention
dermal electrochemical conductance (DEC) +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03495089
NCT03495089N/ACompleted

Feasibility and Effectiveness of Electrochemical Dermal Conductance Measurement for the Screening of Diabetic Neuropathy in Primary Care.

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina·interventional·Posted Apr 11, 2018·Updated Feb 27, 2019

In Brief

A clinical study evaluating dermal electrochemical conductance (DEC) and Monofilament testing for Neuropathy, Diabetic and Diabetes Mellitus, Type 2. Completed, enrolled 147 participants across 3 sites.

Detailed Summary

Diabetes mellitus is the leading cause of polyneuropathy in the Western world. Diabetic neuropathy is a frequent complication of diabetes and may have great clinical transcendence due to pain and possible ulceration of the lower extremities. It is also a relevant cause of morbidity and mortality in patients with diabetes. Although the cause of polyneuropathy in patients with diabetes is only partially known, it has been associated with chronic hyperglycaemia suggesting the possible aetiopathogenic implication of advanced glycosylation end-products. The strategy of choice in the medical management of diabetic neuropathy is early detection since glycaemic control and the use of certain drugs may prevent or slow the development of this disease. Diabetic neuropathy most often presents with a dysfunction of unmyelinated C-fibers, manifested as an alteration of the sweat reflex of the eccrine glands. This dysfunction can now be demonstrated using a newly developed technology which measures dermal electrochemical conductivity. This noninvasive test is easy and cost-effective. The aim of the present study is to evaluate the feasibility and effectiveness of dermal electrochemical conductance measurement (quantitative expression of the sudomotor reflex) as a screening test for the diagnosis of diabetic neuropathy in patients in primary care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 11, 2018
Enrollment StartMay 1, 2015
Primary CompletionMar 1, 2018
Study CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.2 years ago

Interventions

dermal electrochemical conductance (DEC)other

The patient will undergo DEC quantification using the Sudoscan® device.(Sudoscan®, Impeto Medical, France)

Monofilament testingother

Monofilament testing by Semmes-Weinstein 5:07 MFT (10 g),