A Proposed Study of Atherosclerotic Plaques in Leg Arteries

This study is currently recruiting participants.
Verified November 2013 by Southwest Regional Wound Care Center
Sponsor:
Information provided by (Responsible Party):
Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT01803126
First received: September 18, 2012
Last updated: November 12, 2013
Last verified: November 2013

September 18, 2012
November 12, 2013
June 2012
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01803126 on ClinicalTrials.gov Archive Site
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A Proposed Study of Atherosclerotic Plaques in Leg Arteries
A Proposed Study of Atherosclerotic Plaques in Leg Arteries

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Subject with vascular disease or diabetes.

  • Vascular Disease
  • Diabetes
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atherosclerosis
No treatment.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. The subject with identifying leg or legs that were amputated for vascular disease and/or diabetes.
  2. 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.
Both
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No
Contact: Randall D Wolcott, MD 806-793-8869 randy@randallwolcott.com
Contact: Lisa Morrow, LBSW 806-793-8869 lisa@randallwolcott.com
United States
 
NCT01803126
56-RW-024
No
Southwest Regional Wound Care Center
Southwest Regional Wound Care Center
Not Provided
Principal Investigator: Randall D Wolcott, MD Southwest Regional Wound Care Center
Southwest Regional Wound Care Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP