NCT00759889

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Southwest Regional Wound Care Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetic Foot
• Leg Ulcer
• Decubitus Ulcer

Timeline

• Start date: 2007-03-01
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2008-09-25
• Last updated: 2019-01-14

Locations

1 site across 1 country: United States