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

Comparison of HP011-101, HP828-101, and Standard Care in the Management of Stage I-II Pressure Ulcers in Patients With Spinal Cord Injury

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

Study Overview

• Status: Withdrawn
• Conditions: Pressure Ulcers
• Intervention / Treatment: Other: Standard Care; Drug: HP011-101; Device: HP-828-101

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Wound Bed Scores	22 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	22 days

Collaborators and Investigators

• Sponsor: Healthpoint
• Investigators: Study Chair: Herbert B Slade, MD, Healthpoint, Ltd

Study record dates

Study Major Dates

• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): November 1, 2011

Study Registration Dates

• First Submitted: December 3, 2010
• First Submitted That Met QC Criteria: January 7, 2011
• First Posted (Estimate): January 10, 2011

Study Record Updates

• Last Update Posted (Estimate): September 12, 2012
• Last Update Submitted That Met QC Criteria: September 10, 2012
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: 011-101-09-041