Pressure UlcerPRESDIENCT01834417
Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients ( PRESDIE)
A study testing TexiMat in people with Pressure Ulcer, run by Nantes University Hospital at 1 site in France.
Trial summary
Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device. During this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. 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?
- TexiMat
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2013to Jan 2020
- 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
- Patient is male or female, aged ≥ 18
- Patient accepting the initial assessment and the following visits during the protocol
- Written informed consent has been obtained
- Patient having a social assurance
- Spinal cord injury ≤ C6 stable Spinal cord trauma > 1 an
- Main mode of ambulation : own manual wheelchair
Who cannot join
- Aged ≤ 18
- Adults under guardianship
- Patients do not speak French, refusing or unable to be followed
- Pregnant or lactating women
- Person deprived of their liberty by judicial or administrative decision
- Person hospitalised without consent
- Pelvic pressure ulcer ongoing
- Cognitive disorder incompatible with the use of the device, understanding and conduct of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients
Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device. During this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. A control is done every week and the device can be changed until it is returned at the end of the study period.
Read the detailed description
- inclusion visit : recovery of the signed informed-consent form, clinical examination, skin control, seat-pressures control, device 9-position control, delivery of the agenda for noteworthy events
- 3 follow-up visits : noteworthy events check, skin control, cushioncloth control, device 9-position control
- return visit : device return, agenda return, skin control, seat-pressures control
- Conditions
- Pressure Ulcer
- Being tested
- TexiMat
- Keywords
- Pressure ulcer, spinal cord injury, on-board device
- 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.
TexiMatDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra- and inter-patients variability of stored pressures for the whole included population Intra- and inter-patients variability of stored pressures for the whole included population
Intra- and inter-patients variability of stored pressures for the whole included population Measured at the end of the study
Each topic will be equipped with a layer of pressure sensors 32x32. The pressure maps are stored every second rule, which will be of the order of 30 000 maps daily. For each topic, we will be able to calculate the frequency and location of peak pressure
Measured: 4 weeks
Secondary outcomes (1)
Intra- and inter-patients variability of stored pressures for subpopulations
Intra- and inter-patients variability of stored pressures for subpopulations :
- quadriplegic vs paraplegic
- according to high-risk areas for pressure ulcers
- according to noteworthy events
Each topic will be equipped with a layer of pressure sensors 32x32. The pressure maps are stored every second rule, which will be of the order of 30 000 maps daily. For each topic, we will be able to calculate the frequency and location of peak pressure Measured at the end of the study
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 posted17 Apr 2013 (estimated)
- Study start18 Apr 2013
- Primary completionJan 2020
- Study completionJan 2020
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.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte PERROUIN-VERBE, PU-PH, Principal investigator, CHU de Nantes- Hôpital Saint JacquesMarc Le Fort, PH, Study chair, CHU de Nantes-Hôpital Saint JacquesGuy Egon, Study chair, Centre de l'ArcheDjamel Bensmail, PU-PH, Study chair, CH Raymond Poincaré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834417
- Sponsor's protocol ID
- RC11_0009
- Acronym
- PRESDIE
- Status last verified
- Feb 2020
- First submitted
- 8 Apr 2013
- Last updated
- 6 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients
- ClinicalTrials.gov ID
- NCT01834417
- Acronym / sponsor ID
- PRESDIE / RC11_0009
- Conditions
- Pressure Ulcer
- Keywords
- Pressure ulcer, spinal cord injury, on-board device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 18 Apr 2013 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 17 Apr 2013 (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.
Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device. During this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. A control is done every week and the device can be changed until it is returned at the end of the study period.
Detailed description
- inclusion visit : recovery of the signed informed-consent form, clinical examination, skin control, seat-pressures control, device 9-position control, delivery of the agenda for noteworthy events
- 3 follow-up visits : noteworthy events check, skin control, cushioncloth control, device 9-position control
- return visit : device return, agenda return, skin control, seat-pressures control
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is male or female, aged ≥ 18
- Patient accepting the initial assessment and the following visits during the protocol
- Written informed consent has been obtained
- Patient having a social assurance
- Spinal cord injury ≤ C6 stable Spinal cord trauma > 1 an
Key exclusion criteria (8 listed)
- Aged ≤ 18
- Adults under guardianship
- Patients do not speak French, refusing or unable to be followed
- Pregnant or lactating women
- Person deprived of their liberty by judicial or administrative decision
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 |
|---|---|---|
| TexiMat | Device | – |
Primary outcome
Intra- and inter-patients variability of stored pressures for the whole included population Intra- and inter-patients variability of stored pressures for the whole included population
Time frame: 4 weeks
Intra- and inter-patients variability of stored pressures for the whole included population Measured at the end of the study Each topic will be equipped with a layer of pressure sensors 32x32. The pressure maps are stored every second rule, which will be of the order of 30 000 maps daily. For each topic, we will be able to calculate the frequency and location of peak pressure
1 secondary outcome
Intra- and inter-patients variability of stored pressures for subpopulations
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
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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.
Brigitte PERROUIN-VERBE, PU-PH principal investigator
CHU de Nantes- Hôpital Saint Jacques
Marc Le Fort, PH study chair
CHU de Nantes-Hôpital Saint Jacques
Guy Egon study chair
Centre de l'Arche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TexiMat in people with Pressure Ulcer, run by Nantes University Hospital at 1 site in France.
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 8 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 6 Feb 2020. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intra- and inter-patients variability of stored pressures for the whole included population Intra- and inter-patients variability of stored pressures for the whole included population (time frame: 4 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 6 Feb 2020.