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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01433159
• Other study ID #: 011-101-09-043
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2011
• Last updated: January 10, 2014
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2014
• Source: Healthpoint
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Spinal Cord Injuries
• Spinal Cord Injury
• Ulcer

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Carolinas Research	Charlotte	North Carolina
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Healthpoint

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score	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)	baseline, 14 Days	No