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

Neuropathy, Diabetic Clinical Trial

— MEDON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04078516
• Other study ID #: N-20190003
• Status: Completed
• Start date: August 12, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2021
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Men and women minimum 18 years of age and maximum 75 years of age

2. Signed informed consent form

3. Diagnosed with diabetes type I (for group 1-3)

4. 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)

5. Answered questionnaire: PainDETECT

6. Nothing abnormal on initial tests (group 4)

7. Accepted initial screening blood samples

8. 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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuropathy, Diabetic
• Neuropathy, Painful
• Peripheral Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	North Denmark

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory measures	An multi-variant analysis to determine the predictive ability of combinations of primary outcome measures.	End of study (latest december 31 2021).
Primary	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)
Secondary	Validation of PainDETECT in diabetes	Correlation between PainDETECT and DN4 will be reported.	End of study / end of inclusion (when all patients have completed the screening session. Latest 31. november 2021)