A Proposed Study of Atherosclerotic Plaques in Leg Arteries
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 18, 2012
CompletedFirst Posted
Study publicly available on registry
March 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJune 29, 2018
June 1, 2018
4.6 years
September 18, 2012
June 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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
Study Arms (1)
atherosclerosis
No treatment.
Eligibility Criteria
Subject with vascular disease or diabetes.
You may qualify if:
- 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.
You may not qualify if:
- The subject will be excluded if they have had a traumatic amputation which did not involve vascular disease and/or diabetes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southwest Regional Wound Care Center
Lubbock, Texas, 79410, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Randall D Wolcott, MD
Southwest Regional Wound Care Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2012
First Posted
March 4, 2013
Study Start
June 1, 2012
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
June 29, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share