Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound-Related Scien… (NCT00759889) | Clinical Trial Compass
CompletedNot Applicable
Obtaining and Storing Standard of Care Wound Biopsies for Immediate or Future Wound-Related Scientific Study
United States48 participantsStarted 2007-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To analyze and image wounds using microscopy and molecular techniques