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Comparison of HP011-101 to Standard Care in the Management of Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
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.
Details
| Lead sponsor | Healthpoint |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 19 |
| Start date | 2011-09 |
| Completion | 2013-01 |
Conditions
- Pressure Ulcers
- Spinal Cord Injury
Interventions
- HP011-101 (Xenaderm Ointment)
- Standard Care
Primary outcomes
- Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score — baseline, 14 Days
Change from baseline in composite wound bed scores measured as the PUSH total score on Day 15. The PUSH Tool v.3.0, which monitors the three critical parameters that are the most indicative of healing, was used in this study. Scales for the three measurements were: Area = 0 (healthy skin) to 10 (\>24 cm x cm); Exudate = 0 (non) to 3 (heavy); Tissue type = 0 (epithelial tissue) to 4 (necrotic tissue). All values were summed and final values are the cumulative scores. Cumulative Scores = 0 (Best possible outcome: healthy skin/epithelial tissue with no exudate) to 17 (Worst possible outcome: wound \>24 cm x cm, containing necrotic tissue, with heavy exudate)
Countries
United States