Nerve Morphology in Diabetic Patients | NCT00856011

Studies
Nerve Morphology in Diabetic Patients

NCT00856011

Sponsor

Skane University Hospital

Status

Completed

Last Update Posted

Mar 5, 2009Estimated

Enrollment

46Actual

Phase

Not provided

Conditions

Peripheral Neuropathy
Carpal Tunnel Syndrome
Entrapment Neuropathies
Diabetes Complications

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Not provided

Completion Date

Apr 2008Actual

First Submitted Date

Mar 4, 2009

First Submission Date that Met QC Criteria

Mar 4, 2009

First Posted Date

Mar 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2009

Last Update Posted Date

Mar 5, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Diabetic patients with carpal tunnel syndrome
2		Non-diabetic patients with carpal tunnel syndrome

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nerve morphology (Fascicular area, myelinated nerve fiber density, endoneurial capillary density and subperineurial space

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients referred to a specialized hand clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Hand Surgery, Malmo University Hospital		Malmö		SE-205 02	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D002349	Carpal Tunnel Syndrome
D009408	Nerve Compression Syndromes
D048909	Diabetes Complications

Ancestor Terms

ID	Term
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D020423	Median Neuropathy
D020422	Mononeuropathies

Browse Leaves

Not provided

Browse Branches

Not provided