Clinical trial NCT01433159: Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
Official title: Comparison of HP011-101 to Standard Care in the Management of Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pressure Ulcers
Spinal Cord Injury
Keywords: Pressure Ulcers
Spinal Cord Injury
Healthpoint
Xenaderm
011-101
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 19
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score
timeFrame: baseline, 14 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Medical Center, Long Beach
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Tampa
country: United States
facility: James A. Haley Veterans Hospital, Tampa
state: Florida
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Research
state: North Carolina
Study officials:
affiliation: Healthpoint
name: Herbert B Slade, MD
role: STUDY_CHAIR
References: