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
  Purpose

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.


Condition
Diabetic Foot
Leg Ulcer
Decubitus Ulcer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound Related Scientific Study

Resource links provided by NLM:


Further study details as provided by Southwest Regional Wound Care Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 5
Study Start Date: March 2007
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
wound biopsy
diabetic foot,venous leg ulcer, decubitus ulcer

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759889

Contacts
Contact: Randall Wolcott, MD 806-793-8869 randy@randallwolcott.com
Contact: Lisa Morrow, LBSW 806-793-8869 lisa@randallwolcott.com

Locations
United States, Texas
Southwest Regional Wound Care Center Recruiting
Lubbock, Texas, United States, 79410
Contact: Randall Wolcott, MD    806-793-8869    randy@randallwolcott.com   
Contact: Lisa Morrow, LBSW    806-793-8869    lisa@randallwolcott.com   
Principal Investigator: Randall Wolcott, MD         
Sponsors and Collaborators
Southwest Regional Wound Care Center
Investigators
Principal Investigator: Randall Wolcott, MD Southwest Regional Wound Care Center
  More Information

No publications provided

Responsible Party: Randall Wolcott, Prinicipal Investigator, Southwest Regional Wound Care Center
ClinicalTrials.gov Identifier: NCT00759889     History of Changes
Other Study ID Numbers: 56-RW-005
Study First Received: September 24, 2008
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Southwest Regional Wound Care Center:
venous leg ulcer

Additional relevant MeSH terms:
Pressure Ulcer
Leg Ulcer
Ulcer
Diabetic Foot
Skin Ulcer
Skin Diseases
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 21, 2014