Pressure UlcerVASCIPNCT03114345
Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient
A study testing Measurement of interface pressure and Measurement of micro-vascularization related parameters in people with Pressure Ulcer and Bedsore, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Paraplegic patients have defective wound healing for sore below the level of spinal lesion. Defect of vascularization of the healing zone certainly participate to this effect. Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pressure Ulcer, Bedsore, Spinal Cord Injury
- What is being tested?
- Measurement of interface pressure and Measurement of micro-vascularization related parameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2017to 22 Nov 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Educated consent signed,
- Older than 18,
- Paraplegia for at least 6 months,
- Surgery planned for pressure ulcer resection,
Who cannot join
- Dementia,
- Stade IV arteritis non-revascularisable,
- Patient with no health insurance,
- Pregnant women or breast-feeding, patient unable to give his or her educated consent, ward of the state (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9),
- Patient taking part in another study which could impact the local micro-vascularization.
Trial locations and contacts
1 site in 1 country.
France1 site
University Regional Hospital Lapeyronie
Montpellier, Languedoc-Roussillon, 34295
About this study
Paraplegic patients have defective wound healing for sore below the level of spinal lesion. Defect of vascularization of the healing zone certainly participate to this effect. Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. the pressure between the patient body and the surface he/she is lying on) to assess the correlation between mechanical stress in term of pressure applied over time and tissue oxygenation which represent micro-vascular function. The aim of this clinical trial is to correlate the variations of pressure intensities and changes in micro-vascularization. The measure are recorded when paraplegic patient came into the hospital for pressure ulcer related surgery. The patient is laying on his/her mattress on top of a flexible pressure mapping device. The micro-vascularization parameters are measured at the area displaying the peak pressure a few minutes after the beginning of the pressure interface recording and one hour later at the same area. The data generated during this monocentric study will help to achieve a better understanding of the relation between pressure and micro-vascularization. In the mid term, it will provide a better and more patient adapted pressure ulcer prevention.
- Conditions
- Pressure Ulcer, Bedsore, Spinal Cord Injury, Paraplegia
- Being tested
- Measurement of interface pressure, Measurement of micro-vascularization related parameters
- Keywords
- Pressure ulcer, Interface pressure, Pressure mapping device, Monitoring, Microvascularization
- Medical subject headings
- Pressure Ulcer, Spinal Cord Injuries, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of interface pressureOther
A capacitive pressure mapping device (XSensor) is set up on the patient air mattress bed. It records the interface pressure on the whole patient body with one frame every second during one hour. Then the file is saved and the pressure mapping device is removed from the patient hospital bedroom.
Measurement of micro-vascularization related parametersOther
A medical device called O2C, measuring micro-vascularization related parameters (oxygen saturation, hemoglobin quantity and blood flow) is used. The probe (= an optic fibre) is set up lightly on the patient skin or on a transparent adhesive for 1 minute. The median value of the local micro-vascularization parameters are saved on the O2C interface. The location of the measurement is chosen using the pressure mapping device to locate peak pressure area. Then the O2C is removed from the patient hospital bedroom.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Measurement of interface pressure and Measurement of micro-vascularization related parameters Receives: Other: Measurement of interface pressure; Other: Measurement of micro-vascularization related parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the pressure intensity in one area
Pressure intensity is recorded using a mapping pressure device (XSensor), set up on the patient hospital bed. Hemoglobin quantity is measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive.
Measured: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.
Measure of the hemoglobin quantity in the same area
Hemoglobin quantity is measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive.
Measured: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.
Secondary outcomes (1)
Measure of other micro-vascularization related parameters (such as the oxygen saturation and the blood flow) recorded at the same area.
All micro-vascularization related parameters are measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive.
Measured: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start22 Nov 2017
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Why it stopped: Departure of the PhD in charge of the study
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Hill-Rom, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Stefan Matecki, M.D., Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114345
- Sponsor's protocol ID
- 9830
- Acronym
- VASCIP
- Status last verified
- Dec 2021
- First submitted
- 30 Mar 2017
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient
- ClinicalTrials.gov ID
- NCT03114345
- Acronym / sponsor ID
- VASCIP / 9830
- Conditions
- Pressure Ulcer, Bedsore, Spinal Cord Injury, Paraplegia
- Keywords
- Pressure ulcer, Interface pressure, Pressure mapping device, Monitoring, Microvascularization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of the PhD in charge of the study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Hill-Rom, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 14 Apr 2017 (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.
Paraplegic patients have defective wound healing for sore below the level of spinal lesion. Defect of vascularization of the healing zone certainly participate to this effect. Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. the pressure between the patient body and the surface he/she is lying on) to assess the correlation between mechanical stress in term of pressure applied over time and tissue oxygenation which represent micro-vascular function. The aim of this clinical trial is to correlate the variations of pressure intensities and changes in micro-vascularization. The measure are recorded when paraplegic patient came into the hospital for pressure ulcer related surgery. The patient is laying on his/her mattress on top of a flexible pressure mapping device. The micro-vascularization parameters are measured at the area displaying the peak pressure a few minutes after the beginning of the pressure interface recording and one hour later at the same area. The data generated during this monocentric study will help to achieve a better understanding of the relation between pressure and micro-vascularization. In the mid term, it will provide a better and more patient adapted pressure ulcer prevention.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Other: Measurement of interface pressure, Other: Measurement of micro-vascularization related parametersMeasurement of interface pressure and Measurement of micro-vascularization related parameters |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Educated consent signed,
- Older than 18,
- Paraplegia for at least 6 months,
- Surgery planned for pressure ulcer resection,
Key exclusion criteria (5 listed)
- Dementia,
- Stade IV arteritis non-revascularisable,
- Patient with no health insurance,
- Pregnant women or breast-feeding, patient unable to give his or her educated consent, ward of the state (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9),
- Patient taking part in another study which could impact the local micro-vascularization.
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 |
|---|---|---|
| Measurement of interface pressureA capacitive pressure mapping device (XSensor) is set up on the patient air mattress bed. It records the interface pressure on the whole patient body with one frame every second during one hour. Then the file is saved and the pressure mapping device is removed from the patient hospital bedroom. | Other | Single arm |
| Measurement of micro-vascularization related parametersA medical device called O2C, measuring micro-vascularization related parameters (oxygen saturation, hemoglobin quantity and blood flow) is used. The probe (= an optic fibre) is set up lightly on the patient skin or on a transparent adhesive for 1 minute. The median value of the local micro-vascularization parameters are saved on the O2C interface. The location of the measurement is chosen using the pressure mapping device to locate peak pressure area. Then the O2C is removed from the patient hospital bedroom. | Other | Single arm |
Primary outcome
Measure of the pressure intensity in one area
Time frame: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.
Pressure intensity is recorded using a mapping pressure device (XSensor), set up on the patient hospital bed. Hemoglobin quantity is measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive.
Measure of the hemoglobin quantity in the same area
Time frame: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.
Hemoglobin quantity is measured the same day, at a precise area identified on the pressure mapping device (peak pressure), using the O2C - a micro-vascularization device. All measure are non-invasive.
1 secondary outcome
Measure of other micro-vascularization related parameters (such as the oxygen saturation and the blood flow) recorded at the same area.
Time frame: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.
Results and safety
The study was stopped early (reason given: Departure of the PhD in charge of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Stefan Matecki, M.D. principal investigator
CHU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of interface pressure and Measurement of micro-vascularization related parameters in people with Pressure Ulcer and Bedsore, run by University Hospital, Montpellier 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 4 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: stopped early, as of the sponsor's last update on 9 Dec 2021. 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 was stopped early (reason given: Departure of the PhD in charge of the study). Results are not available in the source record.
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?
Measure of the pressure intensity in one area (time frame: Measurements are done the same date as the inclusion, during the patient hospitalization for his/her pressure ulcer related surgery.). The study lists 2 primary outcomes in all. 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 9 Dec 2021.