Pressure Ulcers
Conditions
Brief summary
Testing a drug and a device for the treatment of pressure ulcers, compared with current treatments.
Interventions
DRUGHP011-101
DEVICEHP-828-101
OTHERStandard Care
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Wound Bed Scores | 22 days |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events | 22 days |
Outcome results
None listed