NCT04078516

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Neuropathy, Diabetic
• Neuropathy, Painful

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Perception Threshold Tracking (PTT)	low-current electrical stimulation of both large- and small nerve fibers.
DIAGNOSTIC_TEST	Axon-flair mediated respons	Laser-doppler examination of small blood vessels in the peripheral skin.
DIAGNOSTIC_TEST	Heart rate variability	4 measurements of heart rate.
DIAGNOSTIC_TEST	Quantitative Sensory Testing (QST)	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.
DIAGNOSTIC_TEST	Peripheral blood pressure and transcutaneous oxygen tension	Ankle/brachial index, toe/brachial index, TcpO2.
DIAGNOSTIC_TEST	Magnetic Resonance Imaging (MRI)	MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.
DIAGNOSTIC_TEST	Questionnaires	Questionnaires for detecting painful neuropathy
DIAGNOSTIC_TEST	Corneal Confocal Microscopy /CCM)	Confocal microscopy of the cornea measuring NBD, NFD, NFL

Timeline

• Start date: 2019-08-12
• Primary completion: 2021-08-31
• Completion: 2021-08-31
• First posted: 2019-09-06
• Last updated: 2021-11-02

Locations

1 site across 1 country: Denmark