Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound-Related Scientific Study
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound Related Scientific Study|
- To analyze and image wounds using microscopy and molecular techniques [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
Wound edge biopsies that are obtained through standard of care protocols will be subjected to additional microscopic and molecular analyses following the completion of standard medical assessment.
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
diabetic foot,venous leg ulcer, decubitus ulcer
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759889
|Contact: Randall Wolcott, MDfirstname.lastname@example.org|
|Contact: Lisa Morrow, LBSWemail@example.com|
|United States, Texas|
|Southwest Regional Wound Care Center||Recruiting|
|Lubbock, Texas, United States, 79410|
|Contact: Randall Wolcott, MD 806-793-8869 firstname.lastname@example.org|
|Contact: Lisa Morrow, LBSW 806-793-8869 email@example.com|
|Principal Investigator: Randall Wolcott, MD|
|Principal Investigator:||Randall Wolcott, MD||Southwest Regional Wound Care Center|