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

NCT00762697 | Completed DMC

• 1 other identifier: 56-RW-006
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Insufficiency

Keywords

diabetic, venous insufficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 & Collaborators

• Southwest Regional Wound Care Center: lead

Study Sites (1)

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

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

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Randall Wolcott, MD

  Southwest Regional Wound Care Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2008
• First Posted: September 30, 2008
• Study Start: June 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 26, 2015

Record last verified: 2015-11

Locations

US (1)