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

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.

Study Overview

• Status: Completed
• Conditions: Venous Insufficiency

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79410
      • Southwest Regional Wound Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Southwest Regional Wound Care Center

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Estimate): November 26, 2015
• Last Update Submitted That Met QC Criteria: November 24, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: diabetic, venous insufficiency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: 56-RW-006