NCT04078516|Completed
Methods of Early Detection and Grading Of Diabetic Peripheral Neuropathy (MEDON)
MEDON
Perception Threshold Tracking(PTT): A Novel Method for Early Detection and Grading of Diabetic Peripheral Neuropathy
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MEDON
Perception Threshold Tracking(PTT): A Novel Method for Early Detection and Grading of Diabetic Peripheral Neuropathy
Sponsor study identifier
observational
80
1 country
1
Study Start
August 12, 2019
Actual (reported)Primary Completion
August 31, 2021
Actual (reported)Study Completion
August 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 12, 2019
Actual (reported)August 28, 2019
Actual (reported)September 6, 2019
Actual (reported)August 31, 2021
Actual (reported)August 31, 2021
Actual (reported)Diagnostic value of CCM, PTT, AF and MRI
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.
End of study (when all patients have completed all sessions. Latest 31. december 2021)
Validation of PainDETECT in diabetes
End of study / end of inclusion (when all patients have completed the screening session. Latest 31. november 2021)
Exploratory measures
End of study (latest december 31 2021).
No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
low-current electrical stimulation of both large- and small nerve fibers.
The study population include four well-defined groups of subjects: 1. Patients with Type 1 diabetes and painful diabetic peripheral neuropathy (DPN). 2. Patients with Type 1 diabetes and non-painful diabetic peripheral neuropathy (DPN) 3. Patients with Type 1 diabetes and without diabetic peripheral neuropathy (VPT\<15) (DPN). 4. Healthy control subjects matched for age, BMI, and gender. Diabetes duration, HbA1c, insulin use, ethnicity, and co-morbidities will be matched between group 1, 2 and 3 to best ability.
Aalborg University Hospital
Aalborg, North Denmark, 9000, Denmark
Moussa F, Taleb S, Borbjerg MK, Croosu SS, Morch CD, Frokjaer JB, Hansen TM, Ejskjaer N, Roikjer J. Corneal Immune Cells and Their Relation to Diabetic Peripheral Neuropathy and Neuropathic Pain. Muscle Nerve. 2026 Jan;73(1):72-78. doi: 10.1002/mus.70061. Epub 2025 Nov 17.
Hostrup SN, Lind HP, Croosu SS, Roikjer J, Morch CD, Ejskjaer N, Ostergaard LR, Hansen TM, Frokjaer JB. Multimodal MRI analysis selecting key brain features for machine learning based classification of diabetic neuropathic pain and phenotypes. J Neurol Sci. 2025 Nov 15;478:123701. doi: 10.1016/j.jns.2025.123701. Epub 2025 Sep 15.
Niels Ejskjær, Professor
Steno Diabtes Center North Denmark, Aalborg University Hospital
80 participants (actual enrollment reported by the registry).
First Submitted
August 28, 2019
First Posted
September 6, 2019
Study Start
August 12, 2019
Actual (reported)No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied.
Laser-doppler examination of small blood vessels in the peripheral skin.
4 measurements of heart rate.
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.
Ankle/brachial index, toe/brachial index, TcpO2.
MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.
Questionnaires for detecting painful neuropathy
Confocal microscopy of the cornea measuring NBD, NFD, NFL
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Roikjer J, Croosu SS, Sejergaard BF, Hansen TM, Frokjaer JB, Sondergaard CB, Petropoulos IN, Malik RA, Nielsen E, Morch CD, Ejskjaer N. Diagnostic Accuracy of Perception Threshold Tracking in the Detection of Small Fiber Damage in Type 1 Diabetes. J Diabetes Sci Technol. 2024 Sep;18(5):1157-1164. doi: 10.1177/19322968231157431. Epub 2023 Feb 24.
Roikjer J, Croosu SS, Frokjaer JB, Hansen TM, Arendt-Nielsen L, Ejskjaer N, Morch CD. Perception threshold tracking: validating a novel method for assessing function of large and small sensory nerve fibers in diabetic peripheral neuropathy with and without pain. Pain. 2023 Apr 1;164(4):886-894. doi: 10.1097/j.pain.0000000000002780. Epub 2022 Sep 19.
Primary Completion
August 31, 2021
Actual (reported)Study Completion
August 31, 2021
Actual (reported)Last Updated
November 2, 2021
Record last verified: 2021-11
Data will be shared with collaborating department: Department of Radiology with the purpose of analyzing the data and comparing it to their MRI scans. Data will be shared with Aalborg University with the purpose of analyzing data.
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Source: ClinicalTrials.gov.
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