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Nerve Morphology in Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00856011
Recruitment Status : Completed
First Posted : March 5, 2009
Last Update Posted : March 5, 2009
Information provided by:
Skane University Hospital

Tracking Information
First Submitted Date March 4, 2009
First Posted Date March 5, 2009
Last Update Posted Date March 5, 2009
Study Start Date December 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: March 4, 2009)
Nerve morphology (Fascicular area, myelinated nerve fiber density, endoneurial capillary density and subperineurial space
Original Primary Outcome Measures Same as current
Change History No Changes Posted
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 Nerve Morphology in Diabetic Patients
Official Title Posterior Interosseous Nerve Pathology May Provide Novel Insights Into Both Predisposition and Potential Vascular Basis for the Development of Carpal Tunnel Syndrome in Diabetic Patients.
Brief Summary The underlying basis of carpal tunnel syndrome and the basis of its increased incidence in diabetes are unknown. The aim of this study was to quantified pathology in an uncompressed nerve (posterior interosseous nerve in the forearm between diabetic and non-diabetic patients with CTS.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Biopsies of the posterior interosseous nerve
Sampling Method Probability Sample
Study Population Patients referred to a specialized hand clinic
  • Peripheral Neuropathy
  • Carpal Tunnel Syndrome
  • Entrapment Neuropathies
  • Diabetes Complications
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Diabetic patients with carpal tunnel syndrome
  • 2
    Non-diabetic patients with carpal tunnel syndrome
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 4, 2009)
Original Actual Enrollment Same as current
Actual Study Completion Date April 2008
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria

  • Diagnosis of carpal tunnel syndrome based in clinical history and symptoms
  • Confirmed by nerve conduction studies

Exclusion Criteria

  • Other focal nerve entrapments
  • Cervical radiculopathy
  • Inflammatory joint disease
  • Renal failure
  • Thyroid disorders
  • Previous wrist fracture
  • Long-term exposure to vibrating tools
  • Age under 18
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
Administrative Information
NCT Number NCT00856011
Other Study ID Numbers LU 508-03 (2003)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Niels Thomsen, MD
Study Sponsor Skane University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Skane University Hospital
Verification Date March 2009