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

This study has been terminated.
(Business decision)
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT01433159
First received: September 12, 2011
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Pressure Ulcers
Spinal Cord Injury
Drug: HP011-101 (Xenaderm Ointment)
Drug: Standard Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of HP011-101 to Standard Care in the Management of Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score [ Time Frame: baseline, 14 Days ] [ Designated as safety issue: No ]

    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)



Enrollment: 19
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HP011-101 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.
Active Comparator: Various
Standard Care at each site other than Xenaderm Ointment or other BCT-containing products
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).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433159

Locations
United States, California
VA Medical Center, Long Beach
Long Beach, California, United States, 90822
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
United States, Florida
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States, 33612
United States, New Jersey
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052
United States, North Carolina
Carolinas Research
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Healthpoint
Investigators
Study Chair: Herbert B Slade, MD Healthpoint
  More Information

No publications provided

Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT01433159     History of Changes
Other Study ID Numbers: 011-101-09-043
Study First Received: September 12, 2011
Results First Received: October 9, 2013
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Healthpoint:
Pressure Ulcers
Spinal Cord Injury
Healthpoint
Xenaderm
011-101

Additional relevant MeSH terms:
Pressure Ulcer
Spinal Cord Injuries
Ulcer
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 24, 2014