Case Series of Weekly Applications of dHACM in Treatment of Pressure Ulcers

Inclusion Criteria:

1. Index ulcer characteristics:

1. Ulcer present for ≥ 30 days (Day 0)

2. Index ulcer is located spine, lower back or buttocks

3. Index ulcer area after debridement is ≥ 2 cm² and ≤ 25 cm² at the randomization
visit

4. Ulcer must be Stage II or III as determined by the National Pressure Ulcer
Advisory Panel (NPUAP) pressure ulcer staging system

2. Subject criteria must include:

1. Age 16 or older

2. The subject is willing and able to provide informed consent and participate in
all procedures and follow-up evaluations necessary to complete the study (minors
will provide assent with consent provided by parent)

Exclusion Criteria:

1. Index ulcer characteristics that will make subject ineligible for enrollment:

1. Stage I or IV ulcers as determined by NPUAP pressure ulcer staging system

2. Signs and symptoms of local infection

3. Previous surgical procedure performed at site

4. Known or suspected local skin malignancy at index ulcer site

5. Prior radiation therapy treatment at the index ulcer site

2. Subject criteria that will make subject ineligible for enrollment:

1. Presence of other diseases which, in the Opinion of the Investigator, may result
in allograft failure or has experienced graft failure in the past (examples
include: immune system disorders including Systemic Lupus Erythematosus (SLE),
Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV)

2. Currently taking medications which in the opinion of the investigator may affect
graft incorporation

3. Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or
streptomycin sulfate

4. Any condition(s) that in the opinion of the investigator may seriously
compromises the subject's ability to participate in this study. Examples include:
known history of poor adherence with medical treatment, current drug or alcohol
abuse or a medical/psychiatric condition

5. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or
women of childbearing potential who are planning to become pregnant during the
time of the study OR are unwilling/unable to use acceptable methods of
contraception (birth control pills, barriers, or abstinence)

6. Subjects currently enrolled in this study (i.e. concurrent enrollment in the
study is prohibited)

7. Subject has used any investigational drug(s) or therapeutic device(s) within 30
days preceding screening.

8. Any pathology that would limit the blood supply and compromise healing

9. Subject is a prisoner