Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
Condition: Pressure Ulcers; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Pressure Ulcer; Ulcer; Wounds and Injuries
Intervention: HP011-101 (Xenaderm Ointment); Standard Care
Intervention description: The test article will be applied at approximately the thickness of a dime twice daily, or more often if removed incidental to cleansing for 14 days treatment with HP011 101.; No restrictions are placed on the nature of this care, except that it conform to the typical practices in place during the prior 3 months and that the regimen does not include the use of a BCT ointment (ointments containing Balsam Peru, castor oil and trypsin).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Pressure Ulcers; Spinal Cord Injury; Healthpoint; Xenaderm; 011-101

Summary:

      The trial will compare the effects of 14 days treatment with HP011 101 versus Standard Care
      in subjects with Stage I or II pressure ulcers as a complication of spinal cord injury,
      measured as change from baseline in composite wound bed scores of the PUSH 3.0 tool.
    

Eligibility criteria:

        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.