Pressure UlcersPhase 2NCT01433159
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
A Phase 2 study testing HP011-101 (Xenaderm Ointment) in people with Pressure Ulcers and Spinal Cord Injury, run by Healthpoint at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pressure Ulcers, Spinal Cord Injury
- What is being tested?
- HP011-101 (Xenaderm Ointment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2011to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Carolinas Research
Charlotte, North Carolina, 28203
VA Medical Center, Long Beach
Long Beach, California, 90822
Santa Clara Valley Medical Center
San Jose, California, 95128
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Official title: Comparison of HP011-101 to Standard Care in the Management of Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
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.
- Conditions
- Pressure Ulcers, Spinal Cord Injury
- Being tested
- HP011-101 (Xenaderm Ointment), Standard Care
- Keywords
- Pressure Ulcers, Spinal Cord Injury, Healthpoint, Xenaderm, 011-101
- Medical subject headings
- Pressure Ulcer, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP011-101 (Xenaderm Ointment)Drug
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.
Standard CareDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| HP011-101 | Experimental | Not described Receives: Drug: HP011-101 (Xenaderm Ointment) |
| Various | Active comparator | Standard Care at each site other than Xenaderm Ointment or other BCT-containing products Receives: Drug: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline, 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD, Study chair, Healthpoint
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433159
- Sponsor's protocol ID
- 011-101-09-043
- Status last verified
- Jan 2014
- First submitted
- 12 Sep 2011
- Last updated
- 10 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of HP011-101 to Standard Care in the Management of Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01433159
- Acronym / sponsor ID
- 011-101-09-043
- Conditions
- Pressure Ulcers, Spinal Cord Injury
- Keywords
- Pressure Ulcers, Spinal Cord Injury, Healthpoint, Xenaderm, 011-101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 19 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Posted 10 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HP011-101 | Experimental | Drug: HP011-101 (Xenaderm Ointment) |
| Various | Active comparator | Drug: Standard CareStandard Care at each site other than Xenaderm Ointment or other BCT-containing products |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HP011-101 (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. | Drug | HP011-101 |
| Standard CareNo 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). | Drug | Various |
Primary outcome
Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert B Slade, MD study chair
Healthpoint
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HP011-101 (Xenaderm Ointment) in people with Pressure Ulcers and Spinal Cord Injury, run by Healthpoint at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score (time frame: baseline, 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014.