A Proposed Study of Atherosclerotic Plaques in Leg Arteries

Completed

• Conditions: Diabetes; Vascular Disease

• Registration Number: NCT01803126
• Lead Sponsor: Southwest Regional Wound Care Center

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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-04
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-28
• Last Update Posted: 2018-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Southwest Regional Wound Care Center; 🇺🇸 Lubbock, Texas, United States