HP011-101, HP828-101, and Standard Care for Pressure Ulcers

Study Overview
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Brief Summary
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Testing a drug and a device for the treatment of pressure ulcers, compared with current treatments.

Official Title
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Comparison of HP011-101, HP828-101, and Standard Care in the Management of Stage I-II Pressure Ulcers in Patients With Spinal Cord Injury

Conditions
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Pressure Ulcers

Intervention / Treatment
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* Drug: HP011-101
* Device: HP-828-101
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for the study: Provide informed consent, or informed 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 a pressure ulcer ≥ 5 cm² and ≤ 100 cm² in area (measured as greatest length x perpendicular width of the area of non-blanching erythema or denuded skin, whichever is greater), and will remain hospitalized for at least three weeks. Are capable of maintaining an adequate nutritional status. All female subjects must have a negative urinary pregnancy test. Have, within 12 weeks prior to screening, clinical laboratory test results indicating: Serum albumin ≥ 3.0 g/dL (30 g/L) Alkaline phosphatase, ALT, AST, BUN and serum creatinine levels < 3x upper limit of the Healthpoint normal range (refer to Section 18.1.2) HbA1C ≤ 12% Hemoglobin ≥ 10 g/dL The most recently obtained values must be evaluated against these 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 prior to enrollment, the wound must be expected to remain a Stage I or Stage II partial thickness wound after debridement. Exclusion Criteria: Subjects meeting any of the following criteria are not eligible to enter the study: 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. Are currently being treated with systemic antibiotics. Have received systemic treatment with glucocorticoids for > 10 consecutive days within 1 month 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 wound per visual/clinical assessment. Have a severe burn, immunodeficiency disorder, hematologic disorder, or metastatic malignancy. Have had documented osteomyelitis in the wound area within 6 months prior to screening. The Principal Investigator may declare any subject ineligible for a valid medical reason.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HP011-101<br> | Drug: HP011-101<br> <br> |
| Active Comparator: HP828-101<br> | Device: HP-828-101<br> <br> |
| Other: Standard Care<br> | Other: Standard Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wound Bed Scores |  | 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 22 days |