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DECODING Study (Dermal Electrochemical Conductance in Diabetic Neuropathy)

NCT03495089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2019-02-27

No results posted yet for this study

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.

Conditions

  • Neuropathy, Diabetic
  • Diabetes Mellitus, Type 2

Interventions

DIAGNOSTIC_TEST

dermal electrochemical conductance (DEC)

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

DIAGNOSTIC_TEST

Monofilament testing

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

Sponsors & Collaborators

  • Hospital Mutua de Terrassa

    collaborator OTHER

  • Hospital Universitari Sant Joan de Reus

    collaborator OTHER

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Principal Investigators

  • Bernardo Costa, MD · Jordi Gol Primary Care Research Institute, Catalan Health Institute, Primary Health Care Division, Reus-Barcelona, Catalonia, Spain

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-03-31
Completion
2018-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03495089 on ClinicalTrials.gov