Pressure UlcersPhase 2NCT01273428
HP011-101, HP828-101, and Standard Care for Pressure Ulcers
A Phase 2 study testing HP011-101 and HP-828-101 in people with Pressure Ulcers, run by Healthpoint.
Trial summary
Testing a drug and a device for the treatment of pressure ulcers, compared with current treatments. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- HP011-101 and HP-828-101
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
- Conditions
- Pressure Ulcers
- Being tested
- HP011-101, HP-828-101, Standard Care
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP011-101Drug
HP-828-101Device
Standard CareOther
| Study group | Role | What they receive |
|---|---|---|
| HP011-101 | Active comparator | Not described Receives: Drug: HP011-101 |
| HP828-101 | Active comparator | Not described Receives: Device: HP-828-101 |
| Standard Care | Other | Not described Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wound Bed Scores
Measured: 22 days
Secondary outcomes (1)
Adverse Events
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Primary completionJun 2011 (estimated)
- Study completionNov 2011 (estimated)
Why it stopped: The device test article is no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Herbert B Slade, MD, Study chair, Healthpoint, Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273428
- Sponsor's protocol ID
- 011-101-09-041
- Status last verified
- Jan 2011
- First submitted
- 3 Dec 2010
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of HP011-101, HP828-101, and Standard Care in the Management of Stage I-II Pressure Ulcers in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01273428
- Acronym / sponsor ID
- 011-101-09-041
- Conditions
- Pressure Ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The device test article is no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testing a drug and a device for the treatment of pressure ulcers, compared with current treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HP011-101 | Active comparator | Drug: HP011-101 |
| HP828-101 | Active comparator | Device: HP-828-101 |
| Standard Care | Other | Other: Standard Care |
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)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 | Drug | HP011-101 |
| HP-828-101 | Device | HP828-101 |
| Standard Care | Other | Standard Care |
Primary outcome
Change in Wound Bed Scores
Time frame: 22 days
1 secondary outcome
Adverse Events
Time frame: 22 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
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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, Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HP011-101 and HP-828-101 in people with Pressure Ulcers, run by Healthpoint.
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 11 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: withdrawn, as of the sponsor's last update on 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 in Wound Bed Scores (time frame: 22 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 12 Sep 2012.