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Clinical Trials/NCT01803126
NCT01803126
Completed
Not Applicable

A Proposed Study of Atherosclerotic Plaques in Leg Arteries

Southwest Regional Wound Care Center1 site in 1 country10 target enrollmentJune 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Disease
Sponsor
Southwest Regional Wound Care Center
Enrollment
10
Locations
1
Primary Endpoint
To study the role of biofilm in the hardening of the arteries. The study will evaluate the hardening of the arteries found in legs that have been amputated because of vascular disease and/or diabetes.
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Biofilm has been identified as the major bacterial phenotype contributing to atherosclerosis. It has become very important to evaluate atherosclerosis and the role of biofilm using advanced technologies. It is also important to understand wound biofilm at a genetic and a molecular level.

Detailed Description

High throughput pyrosequencing is opening new doors in nucleic acid analysis. 454 Roche has developed sequencing instrumentation which has the ability to sequence not only genomic DNA (gDNA) but also derivatives of messenger RNA (mRNA) and 16s ribosomal DNA (rDNA). This technology has the potential to survey the nucleic acids involved within a mixed population of species, such as atherosclerotic biofilm. In addition to transcriptome science; proteome, metabolome, and other -omic sciences are advancing rapidly. Examining atherosclerotic plaque using transcriptome, proteome, metabolome, and other -omic approaches may provide valuable insight into the wound's microecology.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
January 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The subject with identifying leg or legs that were amputated for vascular disease and/or diabetes.
  • The subject must be 18 years of age or older.

Exclusion Criteria

  • The subject will be excluded if they have had a traumatic amputation which did not involve vascular disease and/or diabetes.

Outcomes

Primary Outcomes

To study the role of biofilm in the hardening of the arteries. The study will evaluate the hardening of the arteries found in legs that have been amputated because of vascular disease and/or diabetes.

Time Frame: 1 year

Amputated legs will be dissected and en bloc removal of atherosclerotic arteries will be performed within the pathology department of TTUHSC. Preferred artery specimen will be grossly involved arteries that are 5-10 cm in length. The specimens would be flash frozen and stored at -81 degrees within the department until analysis could be undertaken. Frozen tissue would be transferred to the site for further testing (R\&T) once the accrual goal was met. This technology has the potential to survey the nucleic acids involved within a mixed population of species, such as atherosclerotic biofilm. In addition to transcriptome science; proteome, metabolome, and other -omic sciences are advancing rapidly. Examining atherosclerotic plaque using transcriptome, proteome, metabolome, and other -omic approaches may provide valuable insight into the wound's microecology.

Study Sites (1)

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