Clinical trial · Interventional
DECODING Study (Dermal Electrochemical Conductance in Diabetic Neuropathy)
Feasibility and Effectiveness of Electrochemical Dermal Conductance Measurement for the Screening of Diabetic Neuropathy in Primary Care.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes Mellitus, Type 2 | — | UNRESOLVED | — |
| Neuropathy, Diabetic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dermal electrochemical conductance (DEC) | Diagnostic Test | — | UNRESOLVED |
| Monofilament testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- patients with type 2 DM
- description
- Patients with type 2 DM over 40 years of age, with or without symptoms of neuropathy, attended in Primary Care. Intervention(s) to be administered:After verifying the inclusion criteria and receiving written informed consent to participate, during the first visit to the Primary Care centres the medical history of the patient will be obtained and a physical examination will be performed using the Monofilament testing -MFT and the Neuropathy Disability Score-NDS and Utah Early Neuropathy Scale-UENS questionnaires will be given to screen for polyneuropathy-PN. The patient will also undergo dermal electrochemical conductance- DEC quantification using the Sudoscan® device.
- interventionNames
- Diagnostic Test: dermal electrochemical conductance (DEC)
- Diagnostic Test: Monofilament testing
- type
- EXPERIMENTAL
- label
- prediabetes
- description
- Patients with intermediate alterations of glucose metabolism defined as impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) determined by OGTT after 2-hour 75 g oral glucose administration. Intervention(s) to be administered:After verifying the inclusion criteria and receiving written informed consent to participate, during the first visit to the Primary Care centres the medical history of the patient will be obtained and a physical examination will be performed using the Monofilament testing -MFT and the Neuropathy Disability Score-NDS and Utah Early Neuropathy Scale-UENS questionnaires will be given to screen for polyneuropathy-PN. The patient will also undergo dermal electrochemical conductance-DEC quantification using the Sudoscan® device.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * patients with type 2 DM * patients with pre-diabetes * patients without glucose alterations Three main diagnostic categories (normal, pre-diabetes and diabetes) were defined using the WHO criteria based on 2-h postload glucose \[\<7.8 (140 mg/dL), 7.8-11.0 mmol/L (140-200 mg/dL) and / or fasting plasma glucose (6.1-6.9 mmol/L; 110-126 mg/dL) and \>11.1 mmol/L (\>200 mg/dL), respectively. Exclusion Criteria: * Type 1 DM * upper or lower limb amputation (except phalanges), * diagnosis of neuropathy not related to diabetes * neuropathy by entrapment * use of psychoactive substances * chronic alcoholism * malnutrition * treatment with beta-blockers * presence of terminal disease or life expectancy less than 3 years Pregnancy will be ruled out in women (negative pregnancy test) and a possible history of gestational diabetes will also be taken into account.
References
Publications (24)
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- BACKGROUNDTesfaye S, Selvarajah D. Advances in the epidemiology, pathogenesis and management of diabetic peripheral neuropathy. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:8-14. doi: 10.1002/dmrr.2239. PMID 22271716
- BACKGROUNDSaid G. Diabetic neuropathy--a review. Nat Clin Pract Neurol. 2007 Jun;3(6):331-40. doi: 10.1038/ncpneuro0504. PMID 17549059
- BACKGROUNDSamper Bernal D, Monerris Tabasco MM, Homs Riera M, Soler Pedrola M. Etiología y manejo de la neuropatía diabética dolorosa. Rev Soc Esp Dolor. 2010;17(6):286-96. [article in Spanish].
- BACKGROUNDCasellini CM, Parson HK, Richardson MS, Nevoret ML, Vinik AI. Sudoscan, a noninvasive tool for detecting diabetic small fiber neuropathy and autonomic dysfunction. Diabetes Technol Ther. 2013 Nov;15(11):948-53. doi: 10.1089/dia.2013.0129. Epub 2013 Jul 27. PMID 23889506
- BACKGROUNDGore M, Brandenburg NA, Dukes E, Hoffman DL, Tai KS, Stacey B. Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depression, and sleep. J Pain Symptom Manage. 2005 Oct;30(4):374-85. doi: 10.1016/j.jpainsymman.2005.04.009. PMID 16256902
- BACKGROUNDTesfaye S, Stevens LK, Stephenson JM, Fuller JH, Plater M, Ionescu-Tirgoviste C, Nuber A, Pozza G, Ward JD. Prevalence of diabetic peripheral neuropathy and its relation to glycaemic control and potential risk factors: the EURODIAB IDDM Complications Study. Diabetologia. 1996 Nov;39(11):1377-84. doi: 10.1007/s001250050586.