NCT01433159

Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury

Comparison of HP011-101 to Standard Care in the Management of Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Healthpoint · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Ulcers
• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	HP011-101 (Xenaderm Ointment)	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.
DRUG	Standard Care	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).

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-09-13
• Last updated: 2014-02-10
• Results posted: 2014-02-10

Locations

5 sites across 1 country: United States