NCT00856011

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2003

Longer than P75 for all trials

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

December 1, 2003

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
Last Updated

March 5, 2009

Status Verified

March 1, 2009

First QC Date

March 4, 2009

Last Update Submit

March 4, 2009

Conditions

Peripheral NeuropathyCarpal Tunnel SyndromeEntrapment NeuropathiesDiabetes Complications

Outcome Measures

Primary Outcomes (1)

  • Nerve morphology (Fascicular area, myelinated nerve fiber density, endoneurial capillary density and subperineurial space

Study Arms (2)

1

Diabetic patients with carpal tunnel syndrome

2

Non-diabetic patients with carpal tunnel syndrome

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referred to a specialized hand clinic

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Hand Surgery, Malmo University Hospital

Malmo, SE-205 02, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsies of the posterior interosseous nerve

MeSH Terms

Conditions

Peripheral Nervous System DiseasesCarpal Tunnel SyndromeNerve Compression SyndromesDiabetes Complications

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesMedian NeuropathyMononeuropathiesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 5, 2009

Study Start

December 1, 2003

Study Completion

April 1, 2008

Last Updated

March 5, 2009

Record last verified: 2009-03

Locations

SE(1)