PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.

This study seeks to demonstrate how PuraPly® AM performs against standard of care in Stage
II-IV Pressure Ulcers through a prospective randomized controlled study design.

Subjects may be enrolled for up to 24 weeks; if healing occurs prior to week 24, a follow up
healing confirmation visit shall occur two weeks later to confirm maintenance of complete
wound closure and participation may continue up to 24 weeks. Subjects that are randomized to
the SOC group have the opportunity to cross over and receive PuraPly AM at week 12 if their
index ulcer has not healed; they will then be followed for an additional 12 weeks for up to
24 weeks.

Inclusion Criteria:

1. Subject must be at least 18 years of age.

2. Subject has a Stage II-IV pressure ulcer located in the gluteal, ischial, hip, sacral,
coccygeal, and trochanteric, malleolus, or heel area.

3. Pressure ulcer should be present for 4 weeks duration and have a ulcer surface area >
2cm2

4. If multiple ulcers are present, one ulcer must be identified as the index ulcer.

5. The index ulcer is free from active infection at the time of randomization.

6. Willingness to off-load or pressure redistribute ulcer for duration of enrollment

7. The index ulcer has been offloaded for at least 7 days prior to randomization.

8. The index ulcer must have been present for at least 30 days at time of study
enrollment.

9. The index ulcer is separated at least 4 cm from all other ulcers at Study Day -7 and
Study Day 0 (post-debridement) and has a margin of intact skin sufficient for
anchoring of the required study dressing.

10. Subject has read and signed the IRB/IEC approved Informed Consent Form (ICF) before
screening procedures are undertaken.

Exclusion Criteria:

1. Presence of signs and symptoms of infection at the index ulcer site, including but not
limited to cellulitis, acute osteomyelitis, excessive exudate, gangrene or deep tissue
infection

2. The index ulcer is not free of necrotic tissue and is unable to tolerate debridement

3. Non-enteric or unexplored sinus tract

4. Concomitant conditions that in the judgment of the investigator would make the subject
inappropriate for entry to the study

5. Subject has a known sensitivity to porcine materials

6. Subject has a known sensitivity to polyhexamethylenebiguanide (PHMB)