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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01273428
Recruitment Status : Withdrawn (The device test article is no longer available)
First Posted : January 10, 2011
Last Update Posted : September 12, 2012
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Brief Summary:
Testing a drug and a device for the treatment of pressure ulcers, compared with current treatments.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, 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
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Active Comparator: HP011-101 Drug: HP011-101
Active Comparator: HP828-101 Device: HP-828-101
Standard Care Other: Standard Care

Primary Outcome Measures :
  1. Change in Wound Bed Scores [ Time Frame: 22 days ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 22 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01273428

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

Responsible Party: Herbert B. Slade, MD FAAAAI / Chief Medical Officer, Healthpoint, Ltd Identifier: NCT01273428     History of Changes
Other Study ID Numbers: 011-101-09-041
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: January 2011

Additional relevant MeSH terms:
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases