Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal C… (NCT01433159) | Clinical Trial Compass
TerminatedPhase 2
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
Stopped: Business decision
United States19 participantsStarted 2011-09
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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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…
What they're measuring
1
Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score