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Completed

NCT Number: NCT00762697

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for the Collection of Wound Debridement

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

  • The subject must be 18 years of age or older.
  • 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:

  • The subject must be 18 years of age or older.
  • The subject must be mentally competent as determined by the Investigator.
  • The subject must weigh at least 110 lbs.
  • 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*

  • The subject must not be currently incarcerated or pregnant.
  • The subject must not weigh less than 40 lbs.
  • 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.

Sponsors and collaborators

Lead sponsor

Southwest Regional Wound Care Center

Other

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 30, 2008
Registry last updated
Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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