Pressure UlcerDABIRPrUNCT05033470
A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers
A study testing Dabir Mattress Overlay System in people with Pressure Ulcer, run by SerenaGroup, Inc. at 1 site in United States.
Trial summary
This study will evaluate the use of a mattress overlay system to promote the healing of full thickness pressure ulcers. The overlay is placed over the patient's bed making it easier for patients to get in and out of bed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Dabir Mattress Overlay System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 30 Jun 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are male or female, 18 years of age or older.
- Pressure ulcer/injury present for greater than 4 weeks (documented in the medical record).
- Subject has clinical documentation of no visible wound improvement in the post four weeks of standard of care. Objectively, less than 20% healing in the past four weeks from the first treatment visit.
- Study ulcer is a minimum of 2.0 cm2 and a maximum of 50 cm2 at first treatment visit.
- The subject is able and willing to follow the protocol requirements.
- Subject has signed informed consent.
Who cannot join
- Subject has major uncontrolled medical disorder such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
- The Subject has other concurrent conditions that, in the opinion of the Investigator, may compromise subject safety.
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Subject is pregnant or breast feeding.
- Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
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- Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the l 30 days preceding the first treatment visit.
- Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of treatment visit 1.
- Known HbA1C >12%.
- Mini-nutritional assessment Malnutrition Indication score <17.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
SunnyView
Butler, Pennsylvania, 16001
Laura Serena, lserena@serenagroups.com
About this study
Official title: A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers (DABIRPrU)
This study will evaluate the use of a mattress overlay system to promote the healing of full thickness pressure ulcers. The overlay is placed over the patient's bed making it easier for patients to get in and out of bed. In addition, the overlay has blue tooth capabilities that will allow clinicians to remotely monitor adherence with the device.
Read the detailed description
The study is a multi-center, prospective, study designed to evaluate the use of an alternating mattress overlay in the treatment of stage 3 pressure ulcers. After screening, eligible subjects will receive a mattress overlay system for the 4 weeks of treatment. The mattress is fitted to the patient's bed/mattress in his/her home or skilled nursing facility (SNF). Patients responding to the offloading regimen (percent wound area reduction >20% at 4 weeks) may use the overlay for up to 12 additional weeks. The SOC in this study is debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling.
- Conditions
- Pressure Ulcer
- Being tested
- Dabir Mattress Overlay System
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabir Mattress Overlay SystemDevice
Also called standard of care
Dabir Surface mattress overlay system consists of a controller and a low-profile alternating pressure (AP) surface (placed over a non-powered mattress) with hundreds of air-filled geometric nodes arranged in rows. . The multiple rows of nodes inflate and deflate in alternating sequence every five minutes. During deflation phase, the skin and soft tissues experience reduced pressure/loading and enhanced perfusion. In conjunction with Standard of Care: Debridement, Proper moisture balance, off-loading, reduce bacterial burden and nutritional counseling.
| Study group | Role | What they receive |
|---|---|---|
| Dabir Surface Mattress Overlay System | Experimental | Eligible patients are treated with a mattress overlay system and standard of care (debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling). Subjects will be seen weekly for 4 weeks. Patients who respond to the offloading device, may use the overlay for an additional 12 weeks with monthly follow-up visits in the clinic or their home. Subjects undergo study procedures on a weekly basis. Receives: Device: Dabir Mattress Overlay System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Reduction in Surface Area
The percentage change in ulcer size (wound area reduction) from baseline to 4 week completion
Measured: 4 week
Secondary outcomes (1)
Pain assessment
Assessment of the pain level linked to the wound, using a numeric pain scale. Numeric Pain Scale from 0-10 anchored by word descriptors at each end. A numerical scale will be used to assess pain. Subject will be asked to indicate a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by "word descriptors" at each end, as "no pain" on the left side and "worst possible pain" on the right side of the number line. The number 0 represents "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain". The subject indicates the level of pain intensity by selecting a number on the line that represents their perception of their current state.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start4 Oct 2021
- Primary completion1 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies 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
- Model description
- Multi-center prospective pilot study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Collaborators
- Dabir Surfaces Inc
- Responsible party
- Sponsor
- Investigators
- Laura Serena, Study director, cro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033470
- Sponsor's protocol ID
- DABITPrU-001
- Acronym
- DABIRPrU
- Status last verified
- Nov 2022
- First submitted
- 13 Aug 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers (DABIRPrU)
- ClinicalTrials.gov ID
- NCT05033470
- Acronym / sponsor ID
- DABIRPrU / DABITPrU-001
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Collaborators
- Dabir Surfaces Inc
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Sep 2021 (actual)
- 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.
This study will evaluate the use of a mattress overlay system to promote the healing of full thickness pressure ulcers. The overlay is placed over the patient's bed making it easier for patients to get in and out of bed. In addition, the overlay has blue tooth capabilities that will allow clinicians to remotely monitor adherence with the device.
Detailed description
The study is a multi-center, prospective, study designed to evaluate the use of an alternating mattress overlay in the treatment of stage 3 pressure ulcers. After screening, eligible subjects will receive a mattress overlay system for the 4 weeks of treatment. The mattress is fitted to the patient's bed/mattress in his/her home or skilled nursing facility (SNF). Patients responding to the offloading regimen (percent wound area reduction >20% at 4 weeks) may use the overlay for up to 12 additional weeks. The SOC in this study is debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-center prospective pilot study
| Arm | Type | Receives |
|---|---|---|
| Dabir Surface Mattress Overlay System | Experimental | Device: Dabir Mattress Overlay SystemEligible patients are treated with a mattress overlay system and standard of care (debridement, proper moisture balance, reduction of bacterial burden and nutritional counseling). Subjects will be seen weekly for 4 weeks. Patients who respond to the offloading device, may use the overlay for an additional 12 weeks with monthly follow-up visits in the clinic or their home. Subjects undergo study procedures on a weekly basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects are male or female, 18 years of age or older.
- Pressure ulcer/injury present for greater than 4 weeks (documented in the medical record).
- Subject has clinical documentation of no visible wound improvement in the post four weeks of standard of care. Objectively, less than 20% healing in the past four weeks from the first treatment visit.
- Study ulcer is a minimum of 2.0 cm2 and a maximum of 50 cm2 at first treatment visit.
- The subject is able and willing to follow the protocol requirements.
Key exclusion criteria (10 listed)
- Subject has major uncontrolled medical disorder such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- Subject currently being treated for an active malignant disease or subjects with history of malignancy within the wound.
- The Subject has other concurrent conditions that, in the opinion of the Investigator, may compromise subject safety.
- Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
- Subject is pregnant or breast feeding.
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 |
|---|---|---|
| Dabir Mattress Overlay SystemAlso: standard of careDabir Surface mattress overlay system consists of a controller and a low-profile alternating pressure (AP) surface (placed over a non-powered mattress) with hundreds of air-filled geometric nodes arranged in rows. . The multiple rows of nodes inflate and deflate in alternating sequence every five minutes. During deflation phase, the skin and soft tissues experience reduced pressure/loading and enhanced perfusion. In conjunction with Standard of Care: Debridement, Proper moisture balance, off-loading, reduce bacterial burden and nutritional counseling. | Device | Dabir Surface Mattress Overlay System |
Primary outcome
Wound Reduction in Surface Area
Time frame: 4 week
The percentage change in ulcer size (wound area reduction) from baseline to 4 week completion
1 secondary outcome
Pain assessment
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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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.
Laura Serena study director
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1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dabir Mattress Overlay System in people with Pressure Ulcer, run by SerenaGroup, Inc. 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 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: status not confirmed, as of the sponsor's last update on 4 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Serena, MD, FACS (814-688-4000, serena@serenagroups.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Reduction in Surface Area (time frame: 4 week). 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 4 Nov 2022.