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

NCT ID: NCT01433159

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HP011-101

Group Type: EXPERIMENTAL

HP011-101 (Xenaderm Ointment)

Intervention Type: DRUG

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.

Various

Standard Care at each site other than Xenaderm Ointment or other BCT-containing products

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

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

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 determined.

• For ulcers that will require surgical debridement, any debridement modality may be used at baseline, but the ulcer must remain a Stage I or Stage II partial thickness wound after debridement.
• Have spinal cord injuries, which are motor complete or motor incomplete injuries that are based on American Spinal Injury Association (ASIA) Impairment classifications A, B, C, and D.

Exclusion Criteria

• Have a spinal cord injury from, epidural abscess, infection, neurodegenerative process, or malignancy.
• 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.
• Have received systemic treatment with glucocorticoids for > 10 consecutive days within 1 week 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 any open wound per visual/clinical assessment.
• Have a severe burn, immunodeficiency disorder, hematologic disorder, or metastatic malignancy.
• Have had documented osteomyelitis in the ulcer area within 6 months prior to screening.
• Have end-stage renal disease, are receiving treatment for cancer (except for non-melanoma skin cancer within the past five years), or untreated peripheral vascular disease.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healthpoint

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert B Slade, MD

Role: STUDY_CHAIR

Healthpoint

Locations

VA Medical Center, Long Beach

Long Beach, California, United States

Santa Clara Valley Medical Center

San Jose, California, United States

James A. Haley Veterans Hospital, Tampa

Tampa, Florida, United States

Kessler Institute for Rehabilitation

West Orange, New Jersey, United States

Carolinas Research

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

011-101-09-043

Identifier Type: -

Identifier Source: org_study_id