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

PHASE2TerminatedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Pressure UlcersSpinal Cord Injury
Interventions
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).

Trial Locations (5)

28203

Carolinas Research, Charlotte

33612

James A. Haley Veterans Hospital, Tampa, Tampa

90822

VA Medical Center, Long Beach, Long Beach

95128

Santa Clara Valley Medical Center, San Jose

07052

Kessler Institute for Rehabilitation, West Orange

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Healthpoint

INDUSTRY