Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound-Related Scientific Study

Completed

Conditions studied: Diabetic Foot, Leg Ulcer, Decubitus Ulcer

In brief

The objective of this study protocol is to use wound biopsies that have been obtained during standard of care management for further scientific evaluation after standard evaluation by a pathologist. Further imaging and molecular analyses would closely evaluate the presence, architecture, and interaction of wound biofilm and human host tissues.

Key facts

Study ID

NCT00759889

Run by

Southwest Regional Wound Care Center

People needed

48

Starts

2007-03-01

Expected to finish

2018-12-30

Last updated by the study team

2019-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subject must have a wound, which requires a biopsy for at least one of the following reasons:
• The wound is clinically suspicious (raised fibrotic edges, patchy discoloration of the edges, "invasive appearance", or an appearance substantially different from normal chronic wound appearance).
• The wound has been present for over 3 months that has been under standard of care management for at least 1 month and shows no progression towards healing. No progression towards healing is defined as less than 20% reduction in the size of the wound over a 2-week period of time.
• The subject must be at least 18 years of age.
• The ulcer to be biopsied must be greater than 3 centimeters in area.

You may not qualify if…

• Unacceptable risk of bleeding as determined by the investigator.
• Medical or emotional risk associated with the potential biopsy that outweighs the risk of not taking a biopsy as determined by the investigator.
• Note: Vulnerable populations will not be excluded from the study as they are over represented in the chronic wound population, but care will be taken to explain the study to family members and caretakers and other stakeholders in the subject's care, so that concerned parties are in agreement as to the subject's enrollment in the study.

Where it is running

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

Full record on ClinicalTrials.gov

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