A Comparison of the Treatment of Pressure Ulcers in Spinal Cord Injury Subjects With HP011—101 Ointment to That of Treatment With the Sites Usual Standard Care

Inclusion Criteria:

- Provide informed consent, or assent if less than 18 years of age.

- Age 12 years or older, of either sex, and of any race or skin type, provided that
their skin color, in the opinion of the Investigator, will not interfere with the
study assessments.

- Have pressure ulcers ≤ Stage II severity, ≥ 2 cm² and ≤ 100 cm² in aggregate area
(each area will be measured, including ulcer area (cm2), perimeter (cm) and greatest
depth (cm) using the ARANZ Silhouette™ wound imaging and measurement device, and will
remain at the treating facility for at least three weeks.

- In the opinion of the Investigator, are maintaining an adequate nutritional status
and are receiving a full caloric diet, either orally or by tube.

- All female subjects must have a negative urinary pregnancy test at screening.

- Have, within 12 weeks prior to screening, clinical laboratory test results
indicating:

- Alkaline phosphatase, ALT, AST, BUN and serum creatinine levels < 3x upper limit
of the Healthpoint normal range

- HbA1C ≤ 12%

- Hemoglobin ≥ 8 g/dL

- Serum albumin, pre-albumin, and serum total protein measurements must be
collected or obtained. These will serve as baseline covariates for analysis, but
will not be used as inclusion criteria.

The most recently obtained laboratory values must be evaluated against the stated
criteria. If these values are not available from a blood sample within 12 weeks of
screening, blood must be drawn at screening and these laboratory values determined.

- For ulcers that will require surgical debridement, any debridement modality may be
used at baseline, but the ulcer must remain a Stage I or Stage II partial thickness
wound after debridement.

- Have spinal cord injuries, which are motor complete or motor incomplete injuries that
are based on American Spinal Injury Association (ASIA) Impairment classifications A,
B, C, and D.

Exclusion Criteria:

- Have a spinal cord injury from, epidural abscess, infection, neurodegenerative
process, or malignancy.

- Have a known hypersensitivity to any of the test articles or their components.

- Have received therapy with another investigational agent within thirty (30) days of
screening.

- Are pregnant or nursing.

- Have received systemic treatment with glucocorticoids for > 10 consecutive days
within 1 week prior to the start of the study.

- Have received chemotherapy or radiation therapy within the past 5 years.

- Have clinical evidence of bacterial or fungal infection of the any open wound per
visual/clinical assessment.

- Have a severe burn, immunodeficiency disorder, hematologic disorder, or metastatic
malignancy.

- Have had documented osteomyelitis in the ulcer area within 6 months prior to
screening.

- Have end-stage renal disease, are receiving treatment for cancer (except for
non-melanoma skin cancer within the past five years), or untreated peripheral
vascular disease.