Status:
COMPLETED
Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound-Related Scientific Study
Lead Sponsor:
Southwest Regional Wound Care Center
Conditions:
Diabetic Foot
Leg Ulcer
Eligibility:
All Genders
18+ years
Brief Summary
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. F...
Detailed Description
The criteria for considering a wound biopsy in a given patient are a chronic wound (venous leg ulcer, diabetic foot ulcer, decubitus ulcer) that has been present for over two (2) months and has failed...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00759889
Start Date
March 1 2007
End Date
December 30 2018
Last Update
January 14 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Southwest Regional Wound Care Center
Lubbock, Texas, United States, 79410