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

Completed

• Conditions: Diabetic Foot; Decubitus Ulcer; Leg Ulcer

• Registration Number: NCT00759889
• Lead Sponsor: Southwest Regional Wound Care Center

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. Further imaging and molecular analyses would closely evaluate the presence, architecture, and interaction of wound biofilm and human host tissues.

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 to progress towards healing (less than 20% decrease in size over 2-week period of time). Also any suspicious wound in which cancer is strongly considered on a clinical basis should be biopsied immediately without any arbitrary timeline being imposed.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To analyze and image wounds using microscopy and molecular techniques	1 year

Trial Locations

Locations (1)

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