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

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.

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.