- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01803126
A Proposed Study of Atherosclerotic Plaques in Leg Arteries
June 28, 2018 updated by: Southwest Regional Wound Care Center
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Lubbock, Texas, United States, 79410
- Southwest Regional Wound Care Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subject with vascular disease or diabetes.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
atherosclerosis
No treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Randall D Wolcott, MD, Southwest Regional Wound Care Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
September 18, 2012
First Submitted That Met QC Criteria
February 28, 2013
First Posted (Estimate)
March 4, 2013
Study Record Updates
Last Update Posted (Actual)
June 29, 2018
Last Update Submitted That Met QC Criteria
June 28, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 56-RW-024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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