Pressure Ulcers, Spinal Cord Injury
Conditions
Keywords
Pressure Ulcers, Spinal Cord Injury, Healthpoint, Xenaderm, 011-101
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.
Interventions
DRUGHP011-101 (Xenaderm Ointment)
The test article will be applied at approximately the thickness of a dime twice daily, or more often if removed incidental to cleansing for 14 days treatment with HP011 101.
DRUGStandard Care
No restrictions are placed on the nature of this care, except that it conform to the typical practices in place during the prior 3 months and that the regimen does not include the use of a BCT ointment (ointments containing Balsam Peru, castor oil and trypsin).
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score | baseline, 14 Days | Change from baseline in composite wound bed scores measured as the PUSH total score on Day 15. The PUSH Tool v.3.0, which monitors the three critical parameters that are the most indicative of healing, was used in this study. Scales for the three measurements were: Area = 0 (healthy skin) to 10 (\>24 cm x cm); Exudate = 0 (non) to 3 (heavy); Tissue type = 0 (epithelial tissue) to 4 (necrotic tissue). All values were summed and final values are the cumulative scores. Cumulative Scores = 0 (Best possible outcome: healthy skin/epithelial tissue with no exudate) to 17 (Worst possible outcome: wound \>24 cm x cm, containing necrotic tissue, with heavy exudate) |
Countries
United States
Participant flow
Recruitment details
Subjects \>/= 12 yrs of age with Stage I or II pressure ulcers between 1 and 100 cm2 (inclusive) in total aggregate area and maintaining an adequate nutritional status and were receiving a full caloric diet, either orally or by tube
Participants by arm
| Arm | Count |
|---|---|
| HP011-101 Xenaderm Ointment | 9 |
| Various Standard Care Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products | 10 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Various Standard Care | HP011-101 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 3 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 6 Participants | 10 Participants |
| Age, Continuous | 58.6 years STANDARD_DEVIATION 18.4 | 56.0 years STANDARD_DEVIATION 20.7 | 57.4 years STANDARD_DEVIATION 19 |
| Region of Enrollment United States | 10 participants | 9 participants | 19 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 9 | 0 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
Primary
Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score
Change from baseline in composite wound bed scores measured as the PUSH total score on Day 15. The PUSH Tool v.3.0, which monitors the three critical parameters that are the most indicative of healing, was used in this study. Scales for the three measurements were: Area = 0 (healthy skin) to 10 (\>24 cm x cm); Exudate = 0 (non) to 3 (heavy); Tissue type = 0 (epithelial tissue) to 4 (necrotic tissue). All values were summed and final values are the cumulative scores. Cumulative Scores = 0 (Best possible outcome: healthy skin/epithelial tissue with no exudate) to 17 (Worst possible outcome: wound \>24 cm x cm, containing necrotic tissue, with heavy exudate)
Time frame: baseline, 14 Days
Population: Per Protocol Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| HP011-101 | Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score | -3.20 scores on a scale | Standard Deviation 2 |
| Various Standard Care | Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score | -3.47 scores on a scale | Standard Deviation 3.73 |