CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Perception Threshold Tracking (PTT) +7 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT04078516N/ACompleted
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Perception Threshold Tracking(PTT): A Novel Method for Early Detection and Grading of Diabetic Peripheral Neuropathy

Aalborg University Hospital·observational·Posted Sep 6, 2019·Updated Nov 2, 2021

In Brief

An observational study evaluating Perception Threshold Tracking (PTT), Axon-flair mediated respons, and 6 other interventions for Neuropathy, Diabetic and Neuropathy, Painful. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsNeuropathy, Diabetic, Neuropathy, Painful
CountriesDenmark
CollaboratorsAalborg University

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 6, 2019
Enrollment StartAug 12, 2019
Primary CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.8 years ago

Interventions

Perception Threshold Tracking (PTT)other

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

Axon-flair mediated responsother

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

Heart rate variabilityother

4 measurements of heart rate.

Quantitative Sensory Testing (QST)other

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.

Peripheral blood pressure and transcutaneous oxygen tensionother

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

Magnetic Resonance Imaging (MRI)other

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

Questionnairesother

Questionnaires for detecting painful neuropathy

Corneal Confocal Microscopy /CCM)other

Confocal microscopy of the cornea measuring NBD, NFD, NFL