Gene Expression Profiles in Healing and Non-Healing Wounds

This study has two arms: 1) the biopsy arm and 2) the debridement arm. The purpose of the
biopsy arm is to determine whether there are similar patterns of genes being turned on
and/or turned off among people with healing and non-healing wounds. The purpose of the
debridement arm is to (i) identify the nature of bacterial infection and the genes driving
the tissue response to it; and (ii) determine how the biofilm components arrest/paralyze the
immune function.

For the biopsy arm, a single subject (current OSU Comprehensive Wound Center patient) will
provide 2 tissue samples (3 mm punch biopsy samples collected by a wound care physician)
from a single wound over a 4-week time period. The wound and the samples will be categorized
as healing versus non-healing responses on the basis of decreased (healing) or increased
(non-healing) wound area measurements over the 4-week time period. A chronic wound generally
is a wound which shows no signs of significant healing in four weeks or has not healed in
eight weeks. The ability to obtain additional measurements from patients' medical records up
to 12 weeks after enrollment in the study will confirm the healing or non-healing trajectory
of the wound.

For the debridement arm, a single subject (current OSU Comprehensive Wound Center patient)
will be seen 1 time at the CWC during their regularly scheduled wound care visits or during
your scheduled surgery and debrided tissue (foreign matter and dead tissue from a wound)
that is ordinarily discarded will be collected. No additional wound care visits will be
required as all study-related visits will happen during regularly scheduled appointments at
an OSU Comprehensive Wound Center or in the operating room (OR) (if a patient's physician
determines that surgical debridement is required). The ability to obtain additional
measurements from patients' medical records up to 12 weeks after enrollment in the study
will confirm the healing or non-healing trajectory of the wound. Debrided tissue that is
collected will be divided into three parts: A) Necrotic/slough tissue (N); B) Live tissue
determined by consistency and pinkish color, but not perfused (LNP); or C) Red perfused
tissue (LP). If it is difficult to clearly distinguish between the LNP and LP, the two
groups will be combined together. In an effort to identify the infection markers of normal
or impaired healing, we plan to create a database that contains pathogen type, gene and
protein expression profiles and enzymatic activity from infected human wound specimens.

Inclusion Criteria:

- i. Receiving care at an OSU Comprehensive Wound Center, or one of the additional
IRB-approved wound care centers.

Exclusion Criteria:

- i. Unable to provide informed consent

- ii. Therapeutically anticoagulated

- iii. Pregnant females ( > 30 days since 1st day of last menstrual period)

- iv. Receiving chemotherapy for cancer