HP011-101, HP828-101, and Standard Care for Pressure Ulcers

This study has been withdrawn prior to enrollment.
(The device test article is no longer available)
Sponsor:
Information provided by:
Healthpoint
ClinicalTrials.gov Identifier:
NCT01273428
First received: December 3, 2010
Last updated: September 10, 2012
Last verified: January 2011
  Purpose

Testing a drug and a device for the treatment of pressure ulcers, compared with current treatments.


Condition Intervention Phase
Pressure Ulcers
Drug: HP011-101
Device: HP-828-101
Other: Standard Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of HP011-101, HP828-101, and Standard Care in the Management of Stage I-II Pressure Ulcers in Patients With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Healthpoint:

Primary Outcome Measures:
  • Change in Wound Bed Scores [ Time Frame: 22 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 22 days ] [ Designated as safety issue: Yes ]

Enrollment: 0
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HP011-101 Drug: HP011-101
Active Comparator: HP828-101 Device: HP-828-101
Standard Care Other: Standard Care

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must meet all of the following criteria to be eligible for the study:
  • Provide informed consent, or informed 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 a pressure ulcer ≥ 5 cm² and ≤ 100 cm² in area (measured as greatest length x perpendicular width of the area of non-blanching erythema or denuded skin, whichever is greater), and will remain hospitalized for at least three weeks.
  • Are capable of maintaining an adequate nutritional status.
  • All female subjects must have a negative urinary pregnancy test.
  • Have, within 12 weeks prior to screening, clinical laboratory test results indicating:

    • Serum albumin ≥ 3.0 g/dL (30 g/L)
    • Alkaline phosphatase, ALT, AST, BUN and serum creatinine levels < 3x upper limit of the Healthpoint normal range (refer to Section 18.1.2)
    • HbA1C ≤ 12%
    • Hemoglobin ≥ 10 g/dL
  • The most recently obtained values must be evaluated against these 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 prior to enrollment, the wound must be expected to remain a Stage I or Stage II partial thickness wound after debridement.

Exclusion Criteria:

  • Subjects meeting any of the following criteria are not eligible to enter the study:
  • 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.
  • Are currently being treated with systemic antibiotics.
  • Have received systemic treatment with glucocorticoids for > 10 consecutive days within 1 month 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 wound per visual/clinical assessment.
  • Have a severe burn, immunodeficiency disorder, hematologic disorder, or metastatic malignancy.
  • Have had documented osteomyelitis in the wound area within 6 months prior to screening.
  • The Principal Investigator may declare any subject ineligible for a valid medical reason.
  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: NCT01273428

Sponsors and Collaborators
Healthpoint
Investigators
Study Chair: Herbert B Slade, MD Healthpoint, Ltd
  More Information

No publications provided

Responsible Party: Herbert B. Slade, MD FAAAAI / Chief Medical Officer, Healthpoint, Ltd
ClinicalTrials.gov Identifier: NCT01273428     History of Changes
Other Study ID Numbers: 011-101-09-041
Study First Received: December 3, 2010
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014