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Nerve Morphology in Diabetic Patients

This study has been completed.
Sponsor:
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT00856011
First received: March 4, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition
Peripheral Neuropathy
Carpal Tunnel Syndrome
Entrapment Neuropathies
Diabetes Complications

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Skane University Hospital:

Primary Outcome Measures:
  • Nerve morphology (Fascicular area, myelinated nerve fiber density, endoneurial capillary density and subperineurial space [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biopsies of the posterior interosseous nerve


Enrollment: 46
Study Start Date: December 2003
Study Completion Date: April 2008
Groups/Cohorts
1
Diabetic patients with carpal tunnel syndrome
2
Non-diabetic patients with carpal tunnel syndrome

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients referred to a specialized hand clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856011

Locations
Sweden
Dept. of Hand Surgery, Malmo University Hospital
Malmo, Sweden, SE-205 02
Sponsors and Collaborators
Skane University Hospital
  More Information

No publications provided

Responsible Party: Niels Thomsen, MD
ClinicalTrials.gov Identifier: NCT00856011     History of Changes
Other Study ID Numbers: LU 508-03 (2003)
Study First Received: March 4, 2009
Last Updated: March 4, 2009
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Demyelinating Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Substance-Related Disorders
Carpal Tunnel Syndrome
Hereditary Sensory and Motor Neuropathy
 Diabetes Complications
Polyneuropathies
Neurologic Manifestations
Neurotoxicity Syndromes
Median Neuropathy
Mononeuropathies
Sprains and Strains
Wounds and Injuries
Nervous System Malformations
Congenital Abnormalities
Diabetes Mellitus
Signs and Symptoms
Poisoning

ClinicalTrials.gov processed this record on May 23, 2013