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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT00762697
First received: September 29, 2008
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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 Intervention
Diabetic, Venous Insufficiency
Other: wound debridement/ blood samples

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Obtaining and Storing Blood Samples and Debridement Samples for Wound Related Research

Further study details as provided by Southwest Regional Wound Care Center:

Biospecimen Retention:   Samples With DNA

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


Enrollment: 20
Study Start Date: June 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
wound debridement
Blood and debridement samples may be collected from subjects with wounds, but blood samples may also be collected from subjects who are not wounded
Other: wound debridement/ blood samples

Up to 50ml or 500ml of peripheral blood will be collected from each subject every eight (8) weeks.

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects with venous insufficiency, diabetic foot ulcers, decubitus ulcers.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762697

Locations
United States, Texas
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
  More Information

No publications provided

Responsible Party: Randall Wolcott, Principal Investigator, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT00762697     History of Changes
Other Study ID Numbers: 56-RW-006
Study First Received: September 29, 2008
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Southwest Regional Wound Care Center:
diabetic, venous insufficiency

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014