NCT03560505

Brief Summary

This study establishes reference material of selected lower extremity nerves at pre-defined sites with high-resolution ultrasound. Furthermore in this study, high-resolution ultrasound of patients with common fibular compression neuropathy and patients with type 2 diabetic polyneuropathy involving the common fibular nerve will be examined and compared to healthy controls. High-resolution ultrasound measurements will be correlated with history, clinical information and electrophysiological data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

January 14, 2021

Status Verified

June 1, 2018

Enrollment Period

1.8 years

First QC Date

June 7, 2018

Last Update Submit

January 13, 2021

Conditions

UltrasonographyPeroneal Neuropathies

Keywords

Ultrasound reference materialSensitivitySpecificityCommon fibular compression neuropathyType 2 diabetes polyneuropathyIntra-rater reliabilityInter-rater reliability

Outcome Measures

Primary Outcomes (2)

  • Nerve cross-sectional area (CSA)

    The nerve cross-sectional area within the hyperechoic epineurium measured with ultrasound machine software.

    1 year

  • Common fibular nerve fascicle properties

    The amount of visible fascicles and fascicle CSA of the common fibular nerve at measurement sites.

    1 year

Study Arms (2)

Common fibular compression neuropathy

Patients referred for electrophysiological assessment of common fibular compression neuropathy with subsequent confirmation of referral diagnosis. Intervention: Ultrasound protocol.

Diagnostic Test: Ultrasound protocol

Type 2 diabetes polyneuropathy

Patients with type 2 diabetes referred for polyneuropathy involving the common fibular nerve with subsequent confirmation of referral diagnosis. Intervention: Ultrasound protocol.

Diagnostic Test: Ultrasound protocol

Interventions

Ultrasound protocolDIAGNOSTIC_TEST

High-resolution ultrasound protocol at pre-defined sites bilaterally. Pre-defined sites: Sciatic nerve (proximal and distal), tibial nerve (proximal and distal), common fibular nerve (proximal and distal), superficial fibular nerve (proximal and distal) and sural nerve (proximal and distal).

Common fibular compression neuropathyType 2 diabetes polyneuropathy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with common fibular compression neuropathy and patients with type 2 diabetes polyneuropathy involving the common fibular nerve

You may qualify if:

  • Type 2 diabetes polyneuropathy common fibular nerve affection or
  • Common fibular nerve compression neuropathy

You may not qualify if:

  • Lumbar radiculopathy
  • Other competing lower extremity peripheral neuropathy
  • Peripheral vascular disease
  • Hypothyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Neurophysiolgy, Department of Neurology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Peroneal NeuropathiesHypersensitivity

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesImmune System Diseases

Study Officials

  • Erisela Qerama Montvilas, MD, PhD

    Department of Clinical Neurophysiology, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 7, 2018

First Posted

June 18, 2018

Study Start

May 16, 2018

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

January 14, 2021

Record last verified: 2018-06

Locations

DK(1)