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CompletedNCT01834417PRESDIEUpdated Feb 6, 2020

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)

An interventional study of TexiMat in Pressure Ulcer, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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
02

Conditions studied

  • Pressure Ulcer

Keywords

  • Pressure ulcer, spinal cord injury, on-board device
03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's planned enrollment of 90 is above the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria :

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Interventions

  • DeviceTexiMat
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 4 weeks

07

Study locations

1 site
  • CHU Nantes
    Nantes, 44093, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01834417
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Apr 17, 2013
Start date
Apr 18, 2013
Primary completion
Jan 2020
Completion
Jan 2020
Last update
Feb 6, 2020

Study contacts

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
Djamel Bensmail, PU-PH
study chair · CH Raymond Poincaré
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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