Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound-Related Scientific Study
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| ClinicalTrials.gov Identifier: NCT00759889 |
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Recruitment Status :
Completed
First Posted : September 25, 2008
Last Update Posted : January 14, 2019
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Sponsor:
Southwest Regional Wound Care Center
Information provided by (Responsible Party):
Randall Wolcott, Southwest Regional Wound Care Center
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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.
| Condition or disease |
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| Diabetic Foot 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.
| Study Type : | Observational |
| Actual Enrollment : | 48 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound Related Scientific Study |
| Actual Study Start Date : | March 2007 |
| Actual Primary Completion Date : | December 30, 2018 |
| Actual Study Completion Date : | December 30, 2018 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
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wound biopsy
diabetic foot,venous leg ulcer, decubitus ulcer
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Primary Outcome Measures :
- To analyze and image wounds using microscopy and molecular techniques [ Time Frame: 1 year ]
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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:
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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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759889
Locations
| United States, Texas | |
| Southwest Regional Wound Care Center | |
| Lubbock, Texas, United States, 79410 | |
Sponsors and Collaborators
Southwest Regional Wound Care Center
Investigators
| Principal Investigator: | Randall Wolcott, MD | Southwest Regional Wound Care Center |
| Responsible Party: | Randall Wolcott, Prinicipal Investigator, Southwest Regional Wound Care Center |
| ClinicalTrials.gov Identifier: | NCT00759889 |
| Other Study ID Numbers: |
56-RW-005 |
| First Posted: | September 25, 2008 Key Record Dates |
| Last Update Posted: | January 14, 2019 |
| Last Verified: | January 2019 |
Keywords provided by Randall Wolcott, Southwest Regional Wound Care Center:
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venous leg ulcer |
Additional relevant MeSH terms:
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Diabetic Foot Leg Ulcer Pressure Ulcer Ulcer Pathologic Processes Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases |
Foot Ulcer Skin Ulcer Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |