A Proposed Study of Atherosclerotic Plaques in Leg Arteries

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT01803126
First received: September 18, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition
Vascular Disease
Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Proposed Study of Atherosclerotic Plaques in Leg Arteries

Resource links provided by NLM:


Further study details as provided by Southwest Regional Wound Care Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
atherosclerosis
No treatment.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subject with vascular disease or diabetes.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803126

Locations
United States, Texas
Southwest Regional Wound Care Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Southwest Regional Wound Care Center
Investigators
Principal Investigator: Randall D Wolcott, MD Southwest Regional Wound Care Center
  More Information

No publications provided

Responsible Party: Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT01803126     History of Changes
Other Study ID Numbers: 56-RW-024
Study First Received: September 18, 2012
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Southwest Regional Wound Care Center:
atherosclerosis

Additional relevant MeSH terms:
Vascular Diseases
Plaque, Atherosclerotic
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 19, 2014