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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Southwest Regional Wound Care Center
Sponsor:
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier:
NCT00759889
First received: September 24, 2008
Last updated: May 15, 2014
Last verified: May 2014

September 24, 2008
May 15, 2014
March 2007
March 2015   (final data collection date for primary outcome measure)
To analyze and image wounds using microscopy and molecular techniques [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00759889 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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.

  • Diabetic Foot
  • Leg Ulcer
  • Decubitus Ulcer
Not Provided
wound biopsy
diabetic foot,venous leg ulcer, decubitus ulcer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
March 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Randall Wolcott, MD 806-793-8869 randy@randallwolcott.com
Contact: Lisa Morrow, LBSW 806-793-8869 lisa@randallwolcott.com
United States
 
NCT00759889
56-RW-005
Yes
Randall Wolcott, Southwest Regional Wound Care Center
Southwest Regional Wound Care Center
Not Provided
Principal Investigator: Randall Wolcott, MD Southwest Regional Wound Care Center
Southwest Regional Wound Care Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP