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

CompletedOBSERVATIONAL
Enrollment

80

Participants

Timeline

Start Date

August 12, 2019

Primary Completion Date

August 31, 2021

Study Completion Date

August 31, 2021

Conditions
Neuropathy, DiabeticNeuropathy, Painful
Interventions
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

Trial Locations (1)

9000

Aalborg University Hospital, Aalborg

All Listed Sponsors
collaborator

Aalborg University

OTHER

lead

Aalborg University Hospital

OTHER

NCT04078516 - Methods of Early Detection and Grading Of Diabetic Peripheral Neuropathy (MEDON) | Biotech Hunter | Biotech Hunter