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Obtaining and Storing Blood Samples and Debridement Samples for Wound Related Research

NCT ID: NCT00762697

Last Updated: 2015-11-26

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-04-30

Brief Summary

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The intent of this protocol is to obtain blood samples from subjects with or without a wound, so the blood can be used in wound-related scientific studies. It is also the intent of this protocol to salvage debrided wound material that is normally destined for destruction, so it can be used in wound-related scientific studies.

Detailed Description

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The samples will be studied in order to attempt to better understand wounds and their associated barriers to healing. Analytical methods used to examine the blood or debridement can investigate morphological, molecular, immunological, cellular, viral, biochemical, chemical, genetic, and/or transcriptional components of the samples. It is the goal of this study to determine if these tests may be able to provide important insights into the keys of wound healing, wound persistence, or wound deterioration.

Conditions

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Venous Insufficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. The subject must have a full thickness wound.
2. The subject must be a candidate for sharp debridement.
3. The subject must be 18 years of age or older.

Wounded or Otherwise Not Healthy Subjects, Subjects Weighing Less Than 110 lbs., or Subjects Contributing 50ml of Blood or Less:

1. The subject must be 18 years of age or older.
2. The subject must be mentally competent as determined by the Investigator.

Not Wounded and Healthy Subjects Weighing at Least 110 lbs. Who May Contribute Up To 500ml of Blood:

1. The subject must be 18 years of age or older.
2. The subject must be mentally competent as determined by the Investigator.
3. The subject must weigh at least 110 lbs.
4. The subject must have a hemoglobin level that is in or above the normal range within the last 8 (eight) weeks as determined by standard clinical laboratory testing, the copper sulfate test, or a point of care instrument.

Exclusion Criteria

1. The subject must not be currently incarcerated or pregnant.
2. The subject must not weigh less than 40 lbs.
3. If the subject will be contributing more that 50 ml of blood during an 8 (eight) week period, then the subject must not have donated red blood cells within the last 8 (eight) weeks.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southwest Regional Wound Care Center

OTHER

Sponsor Role lead

Responsible Party

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Randall Wolcott

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randall 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-006

Identifier Type: -

Identifier Source: org_study_id