A Proposed Study of Atherosclerotic Plaques in Leg Arteries

NCT ID: NCT01803126

Last Updated: 2018-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Vascular Disease Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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atherosclerosis

No treatment.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Regional Wound Care Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Randall D Wolcott, MD

Role: PRINCIPAL_INVESTIGATOR

Southwest Regional Wound Care Center

Locations

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Southwest Regional Wound Care Center

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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56-RW-024

Identifier Type: -

Identifier Source: org_study_id

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