Pressure UlcersP400NCT01139879
P400 for Stage II-IV Pressure Ulcers in Home and Extended Care
A study testing P400 mattress in people with Pressure Ulcers, run by Hill-Rom at 1 site in United States.
Trial summary
To assess the efficacy of a pressure ulcer treatment mattress, the P400 mattress, in the treatment of multiple Stage II or one or more large Stage III or IV pressure ulcers in the home care and extended care (nursing home) environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- P400 mattress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has multiple Stage II pressure ulcers or at least one Stage III or IV pressure ulcer(s) (as per National Pressure Ulcer Advisory Panel Staging guidelines) located either on the trunk or pelvis (which would include trochanter and ischial ulcers ) having a clean wound bed of less than or equal to 25% necrotic tissue at the base of the pressure ulcer.
- Subjects may have heel ulcers, however these ulcers may not be considered a target study ulcer.
- Subject, or legally authorized representative is able to provide informed consent
- Subject weighs between 70 and 350 pounds
- Subject's nutritional status is thought to be adequate to support wound healing
- Subject qualifies for a Group 2 support surface (Target study ulcer must be at least 8 cm^2 in area to qualify)
Who cannot join
- Subject's target ulcer is unstageable due to eschar or necrosis or a suspected Deep Tissue Injury may be located at the base of the wound.
- Subject has unresolved systemic infection, or pressure ulcer infection, or a history of osteomyelitis, or greater than 25% eschar or necrotic tissue present in the wound bed.
- Patient has already been enrolled in this study
- Patient has a recent history of non-compliance with pressure ulcer offloading, repositioning, or other areas of the treatment care plan, which would jeopardize wound healing if continued.
- Care plan goals are palliative
Trial locations and contacts
1 site in 1 country.
United States1 site
Southwest Regional Wound Care Center
Lubbock, Texas, 79410
About this study
Official title: Assessment of the Incidence and Treatment of Stage II -IV Pressure Ulcers in the Home Care or Extended Care Environments Utilizing the P400 Mattress
To assess the efficacy of a pressure ulcer treatment mattress, the P400 mattress, in the treatment of multiple Stage II or one or more large Stage III or IV pressure ulcers in the home care and extended care (nursing home) environment.
Read the detailed description
Subjects will be recruited from those presenting to the wound clinic and meet the inclusion criteria. A total of 30 evaluable subjects will be recruited for this study from up to 2 wound care clinics /home health agencies (15 in Home Care and 15 in Extended Care). Subjects will be followed by weekly wound assessments for a period of 12 weeks or until their wounds heal. The outcome measurement is the rate of healing over the 12 week period.
- Conditions
- Pressure Ulcers
- Being tested
- P400 mattress
- Keywords
- Pressure Ulcer treatment Mattresses, Home Care, Extended Care, Wound measurements
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P400 mattressDevice
The P400 mattress will be placed for a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| P400 support surface | Experimental | All patients will receive the P400 mattress Receives: Device: P400 mattress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Ulcer Surface Area at Week 12
The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.
Measured: 12 Weeks
Secondary outcomes (2)
Incidence of New Ulcers
incidence of new ulcers while on the study surface
Measured: 12 Weeks
Healing Rate Per Week
The mean change in area per week for all ulcers
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall Wolcott, MD, Principal investigator, Randall Wolcott and Assoiciates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139879
- Sponsor's protocol ID
- CR-0092
- Acronym
- P400
- Status last verified
- Nov 2015
- First submitted
- 7 Jun 2010
- Last updated
- 17 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Incidence and Treatment of Stage II -IV Pressure Ulcers in the Home Care or Extended Care Environments Utilizing the P400 Mattress
- ClinicalTrials.gov ID
- NCT01139879
- Acronym / sponsor ID
- P400 / CR-0092
- Conditions
- Pressure Ulcers
- Keywords
- Pressure Ulcer treatment Mattresses, Home Care, Extended Care, Wound measurements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Posted 17 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of a pressure ulcer treatment mattress, the P400 mattress, in the treatment of multiple Stage II or one or more large Stage III or IV pressure ulcers in the home care and extended care (nursing home) environment.
Detailed description
Subjects will be recruited from those presenting to the wound clinic and meet the inclusion criteria. A total of 30 evaluable subjects will be recruited for this study from up to 2 wound care clinics /home health agencies (15 in Home Care and 15 in Extended Care). Subjects will be followed by weekly wound assessments for a period of 12 weeks or until their wounds heal. The outcome measurement is the rate of healing over the 12 week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P400 support surface | Experimental | Device: P400 mattressAll patients will receive the P400 mattress |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has multiple Stage II pressure ulcers or at least one Stage III or IV pressure ulcer(s) (as per National Pressure Ulcer Advisory Panel Staging guidelines) located either on the trunk or pelvis (which would include trochanter and ischial ulcers ) having a clean wound bed of less than or equal to 25% necrotic tissue at the base of the pressure ulcer.
- Subjects may have heel ulcers, however these ulcers may not be considered a target study ulcer.
- Subject, or legally authorized representative is able to provide informed consent
- Subject weighs between 70 and 350 pounds
- Subject's nutritional status is thought to be adequate to support wound healing
Key exclusion criteria (5 listed)
- Subject's target ulcer is unstageable due to eschar or necrosis or a suspected Deep Tissue Injury may be located at the base of the wound.
- Subject has unresolved systemic infection, or pressure ulcer infection, or a history of osteomyelitis, or greater than 25% eschar or necrotic tissue present in the wound bed.
- Patient has already been enrolled in this study
- Patient has a recent history of non-compliance with pressure ulcer offloading, repositioning, or other areas of the treatment care plan, which would jeopardize wound healing if continued.
- Care plan goals are palliative
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 |
|---|---|---|
| P400 mattressThe P400 mattress will be placed for a period of 12 weeks. | Device | P400 support surface |
Primary outcome
Change From Baseline in Ulcer Surface Area at Week 12
Time frame: 12 Weeks
The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.
2 secondary outcomes
Incidence of New Ulcers
Time frame: 12 Weeks
Healing Rate Per Week
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- 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.
Randall Wolcott, MD principal investigator
Randall Wolcott and Assoiciates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P400 mattress in people with Pressure Ulcers, run by Hill-Rom at 1 site 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2015). 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 Ulcer Surface Area at Week 12 (time frame: 12 Weeks). 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 17 Dec 2015.