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High-resolution Ultrasound in Lower Extremity Nerves and Common Fibular Neuropathies.

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ClinicalTrials.gov Identifier: NCT03560505
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Sándor Beniczky, Aarhus University Hospital

Tracking Information
First Submitted Date June 7, 2018
First Posted Date June 18, 2018
Last Update Posted Date June 19, 2018
Actual Study Start Date May 16, 2018
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2018)
  • Nerve cross-sectional area (CSA) [ Time Frame: 1 year ]
    The nerve cross-sectional area within the hyperechoic epineurium measured with ultrasound machine software.
  • Common fibular nerve fascicle properties [ Time Frame: 1 year ]
    The amount of visible fascicles and fascicle CSA of the common fibular nerve at measurement sites.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03560505 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title High-resolution Ultrasound in Lower Extremity Nerves and Common Fibular Neuropathies.
Official Title A Prospective Study of High-resolution Ultrasonography in Examination of Lower Extremity Peripheral Nerves in Patients With Compression Neuropathies and in Healthy Controls.
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.
Detailed Description

The usual diagnostic work-up of patients referred for lower-extremity neuropathy includes clinical examination, biochemical tests (blood and cerebrospinal fluid), electrophysiological assessment and if necessary nerve biopsy. The electrophysiological assessment usually consists of nerve conduction studies (NCS) and electromyography (EMG). While electrophysiological measurements generally give information about the function of nerves, high-resolution ultrasound may provide information about the structure of nerves.

High-resolution ultrasound examination has shown promising results as a supplementary tool in the diagnostic work-up of various peripheral neuropathies. The clinical utility of ultrasound in the diagnosis of common fibular neuropathies, however, calls for further elucidation.

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, as well as each other. High-resolution ultrasound measurements will be correlated with history, clinical information and electrophysiological data.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with common fibular compression neuropathy and patients with type 2 diabetes polyneuropathy involving the common fibular nerve
Condition
  • Ultrasonography
  • Peroneal Neuropathies
Intervention Diagnostic Test: Ultrasound protocol
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).
Study Groups/Cohorts
  • Common fibular compression neuropathy

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

    Intervention: Ultrasound protocol.

    Intervention: 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.

    Intervention: Diagnostic Test: Ultrasound protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 7, 2018)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Lumbar radiculopathy
  • Other competing lower extremity peripheral neuropathy
  • Peripheral vascular disease
  • Hypothyroidism
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Selim Kilic, MS-V +4541578461 selim.kilic@post.au.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT03560505
Other Study ID Numbers USCF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Sándor Beniczky, Aarhus University Hospital
Study Sponsor Sándor Beniczky
Collaborators Aarhus University Hospital
Investigators
Study Director: Erisela Qerama Montvilas, MD, PhD Department of Clinical Neurophysiology, Aarhus University Hospital
PRS Account Aarhus University Hospital
Verification Date June 2018