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

Completed

• Conditions: Venous Insufficiency

• Registration Number: NCT00762697
• Lead Sponsor: Southwest Regional Wound Care Center

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.

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 Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Southwest Regional Wound Care Center; 🇺🇸 Lubbock, Texas, United States