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A Proposed Study of Atherosclerotic Plaques in Leg Arteries

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ClinicalTrials.gov Identifier: NCT01803126
Recruitment Status : Active, not recruiting
First Posted : March 4, 2013
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Vascular Disease Diabetes

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.

Study Design

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Proposed Study of Atherosclerotic Plaques in Leg Arteries
Study Start Date : June 2012
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
atherosclerosis
No treatment.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT01803126     History of Changes
Other Study ID Numbers: 56-RW-024
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Southwest Regional Wound Care Center:
atherosclerosis

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