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

NCT01273428 | Withdrawn Phase 2

• 1 other identifier: 011-101-09-041
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pressure Ulcers

Outcome Measures

Primary Outcomes (1)

• Change in Wound Bed Scores

  22 days

Secondary Outcomes (1)

• Adverse Events

  22 days

Study Arms (3)

HP011-101

ACTIVE COMPARATOR

Drug: HP011-101

HP828-101

ACTIVE COMPARATOR

Device: HP-828-101

Standard Care

OTHER

Other: Standard Care

Interventions

HP011-101 DRUG

HP011-101

HP-828-101 DEVICE

HP828-101

Standard Care OTHER

Standard Care

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthpoint: lead

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Herbert B Slade, MD

  Healthpoint, Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: January 10, 2011
• Primary Completion: June 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 12, 2012

Record last verified: 2011-01