Clincosm LogoSign in Get a demo

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

Sponsor
Southwest Regional Wound Care Center (Other)
Overall Status
Completed
CT.gov ID
NCT00762697
Collaborator
(none)
20
Enrollment
1
Location
58
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Obtaining and Storing Blood Samples and Debridement Samples for Wound Related Research
    Study Start Date :
    Jun 1, 2007
    Actual Primary Completion Date :
    Apr 1, 2012
    Actual Study Completion Date :
    Apr 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      Inclusion Criteria for the Collection of Wound Debridement

      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.

      4. The subject must be mentally competent as determined by the Investigator Inclusion Criteria for the Collection of Blood

      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:

      Exclusion Criteria for the Collection of Wound Debridement and Blood Collection*

      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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Southwest Regional Wound Care Center Lubbock Texas United States 79410

      Sponsors and Collaborators

      • Southwest Regional Wound Care Center

      Investigators

      • Principal Investigator: Randall Wolcott, MD, Southwest Regional Wound Care Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Randall Wolcott, Principal Investigator, Southwest Regional Wound Care Center
      ClinicalTrials.gov Identifier:
      NCT00762697
      Other Study ID Numbers:
      • 56-RW-006
      First Posted:
      Sep 30, 2008
      Last Update Posted:
      Nov 26, 2015
      Last Verified:
      Nov 1, 2015
      Keywords provided by Randall Wolcott, Principal Investigator, Southwest Regional Wound Care Center
      diabetic, venous insufficiency
      Additional relevant MeSH terms:
      Venous Insufficiency

      Study Results

      No Results Posted as of Nov 26, 2015