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Completed

NCT Number: NCT04078516

Methods of Early Detection and Grading Of Diabetic Peripheral Neuropathy (MEDON)

MEDON aims to examine new methods for early detection and grading of diabetic peripheral neuropathy focusing on both small- and large nerve fibers. Furthermore, MEDON aims to describe differences between people with classic diabetic peripheral neuropathy and those with painful diabetic neuropathy.

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Key information

Conditions

Neuropathy, Diabetic Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Neuropathy, Painful Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women minimum 18 years of age and maximum 75 years of age
  • Signed informed consent form
  • Diagnosed with diabetes type I (for group 1-3)
  • Diagnosed with DPN defined as a threshold above 25-volt biothesiometry or absent feeling on the big toe using 10g-monofilament. (for group 1-2)
  • Answered questionnaire: PainDETECT
  • Nothing abnormal on initial tests (group 4)
  • Accepted initial screening blood samples
  • MRI-compatible participant

Exclusion criteria

  • 1. Current or previous alcohol- or drug abuse 2. Abnormal screening blood samples 3. Not being able to understand Danish written and/or verbally 4. Not being able to corporate to examination (e.g. not being able to speak, suffering from senile dementia etc.) 5. Previous chemotherapy or intake of experimental medicine 6. Active HSV- or VZV-infection or known HIV 7. Known severe skin disease 8. Known neural damage or disease in the neural system (e.g. MS, Guillain-Barre etc.) 9. Critical limb ischemia defined as in current clinical consensus 10. Allergy or intolerance to histamine or inability to make do without for one day 11. Pregnancy 12. Active cancer-disease

Treatment and study plan

Perception Threshold Tracking (PTT)

Diagnostic Test

low-current electrical stimulation of both large- and small nerve fibers.

Axon-flair mediated respons

Diagnostic Test

Laser-doppler examination of small blood vessels in the peripheral skin.

Other names: Laser-doppler

Heart Rate Variability

Diagnostic Test

4 measurements of heart rate.

Other names: Vagus TM

Quantitative sensory testing (QST)

Diagnostic Test

Seven tests measuring 13 parameters including heat- and cold-detection and pain thresholds, mechanical pain treshold, mechanical detection threshold, pressure pain treshold and vibration threshold.

Other names: German Research Network on Neuropathic Pain (DFNS) standard protocol

Peripheral blood pressure and transcutaneous oxygen tension

Diagnostic Test

Ankle/brachial index, toe/brachial index, TcpO2.

Other names: Perimed 6000

Magnetic Resonance Imaging (MRI)

Diagnostic Test

MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.

Questionnaires

Diagnostic Test

Questionnaires for detecting painful neuropathy

Other names: PainDETECT, Douleur Neuropathique 4

Corneal Confocal Microscopy /CCM)

Diagnostic Test

Confocal microscopy of the cornea measuring NBD, NFD, NFL

Primary outcomes

  1. Diagnostic value of CCM, PTT, AF and MRI

    Time frame: End of study (when all patients have completed all sessions. Latest 31. december 2021)

    Using Quantitative Sensory Testing (small fibers) and conventional nerve conduction studies (large fibers) as golden standards, we will determine the prognostic value of:

    Perception Threshold Tracking Corneal Confocal Microscopy Axon-flair mediated response MRI-scans in detecting neuropathy. Sensitivity and specificity will be reported.

    OBS! Tests will be tested in the initial groups and AFTER a group re-arrangement based on results from QST and NCS.

Secondary outcomes

  1. Validation of PainDETECT in diabetes

    Time frame: End of study / end of inclusion (when all patients have completed the screening session. Latest 31. november 2021)

    Correlation between PainDETECT and DN4 will be reported.

Other outcomes

  1. Exploratory measures

    Time frame: End of study (latest december 31 2021).

    An multi-variant analysis to determine the predictive ability of combinations of primary outcome measures.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aalborg University

Registry information

Official study title

Perception Threshold Tracking(PTT): A Novel Method for Early Detection and Grading of Diabetic Peripheral Neuropathy

Acronym: MEDON

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2019
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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