Pressure UlcerOPUSNCT04113148
Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration
An observational study of Pressure Ulcer, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Pressure ulcers are common, distressing and expensive. Currently scoring systems and checks by nursing staff are carried out to assess a patient's risk of developing a pressure ulcer. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Physiological measurements from heel
- How many people
- 170 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2019to Jan 2020
- Phase
- Observational
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: From in patient population
Who may be able to join
- HEALTHY VOLUNTEERS:
- Able to give consent
- Male or female
- Over the age of 18 years
- No known peripheral vascular disease
- No known tissue damage
Show all 15Show fewer
- Able to read and understand basic English language
- PATIENTS:
- Able to give consent
- Male or female
- Over the age of 18 years
- Either at risk (Braden scale <17) or confirmed Category 1 or 2 PU or confirmed DTI
- Well enough to attend lab without any attachments (IV fluids, IV medications, oxygen)
- Able to transfer to bed with assistance of one
- Able to read and understand basic English Language
Who cannot join
- HEALTHY VOLUNTEERS:
- Presence of tissue damage or ulceration in the foot
- Known peripheral vascular disease
- Known hypersensitivity to fixation tape
- Presence of a pacemaker
- Participants unable to or refusing to give informed consent
Show all 12Show fewer
- PATIENTS:
- Known hypersensitivity to fixation tape
- Participants unable to or refusing to give informed consent
- Unable to transfer to bed with assistance of one.
- Requiring more than routine observations and requiring attachments (IV fluids, IV medications, oxygen)
- Presence of a pacemaker
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Vascular Dept
Newcastle, Tyne and Wear, NE7 7DN
Emma EF Scott, MBChB, 01912336161, emma.scott@nuth.nhs.uk
About this study
Official title: Optical Pressure Ulcer Study: Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration
Pressure ulcers are common, distressing and expensive. Currently scoring systems and checks by nursing staff are carried out to assess a patient's risk of developing a pressure ulcer.
The investigators would like to see whether non-invasive measurements can be taken from patients to predict who might be at risk of pressure ulcers to allow us to intervene and reduce the risk of it happening.
Read the detailed description
Pressure ulcers are common, distressing and expensive. Currently scoring systems and checks by nursing staff are carried out to assess a patient's risk of developing a pressure ulcer.
The aim is to investigate whether non-invasive physiological measurements can be taken from patients to predict who might be at risk of pressure ulcers to allow us to intervene and reduce the risk.
- Conditions
- Pressure Ulcer
- Being tested
- Physiological measurements from heel
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological measurements from heelOther
Measurements of blood flow, tissue oxygen saturation, temperature, pressure
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Physiological measurements from heel over 60 minute period Receives: Other: Physiological measurements from heel | |
| At risk of Pressure Ulcer | Physiological measurements from heel over 60 minute period Receives: Other: Physiological measurements from heel | |
| Confirmed Catefory I Pressure Ulcer | Physiological measurements from heel over 60 minute period Receives: Other: Physiological measurements from heel | |
| Suspected Deep Tissue Injury | Physiological measurements from heel over 60 minute period Receives: Other: Physiological measurements from heel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laser Doppler Flowmetry
Laser light to assess perfusion of heel
Measured: 20 minutes
Spectrometry
Light spectrometry to assess tissue oxygen saturation of the heel
Measured: 20 minutes
Impedance
Measurement of oedema of the heel
Measured: 5 minutes
Temperature
Thermal image of heel to assess skin temperature
Measured: 5 minutes
Secondary outcomes (1)
Co-morbidities
The presence of peripheral arterial disease, ischaemic heart disease, diabetes and previous pressure ulcers
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Jun 2019
- Primary completionNov 2019 (estimated)
- Study completionJan 2020 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerard Stansby, MBBS, Principal investigator, Newcastle upon Tyne NHS Hospitals Foundation Trust/Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113148
- Sponsor's protocol ID
- FO18022
- Other IDs
- 8779
- Acronym
- OPUS
- Status last verified
- Oct 2019
- First submitted
- 4 Jul 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is anonymised
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Pressure Ulcer Study: Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration
- ClinicalTrials.gov ID
- NCT04113148
- Acronym / sponsor ID
- OPUS / FO18022
- Conditions
- Pressure Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 2 Oct 2019 (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.
Pressure ulcers are common, distressing and expensive. Currently scoring systems and checks by nursing staff are carried out to assess a patient's risk of developing a pressure ulcer.
The investigators would like to see whether non-invasive measurements can be taken from patients to predict who might be at risk of pressure ulcers to allow us to intervene and reduce the risk of it happening.
Detailed description
Pressure ulcers are common, distressing and expensive. Currently scoring systems and checks by nursing staff are carried out to assess a patient's risk of developing a pressure ulcer.
The aim is to investigate whether non-invasive physiological measurements can be taken from patients to predict who might be at risk of pressure ulcers to allow us to intervene and reduce the risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | – | Other: Physiological measurements from heelPhysiological measurements from heel over 60 minute period |
| At risk of Pressure Ulcer | – | Other: Physiological measurements from heelPhysiological measurements from heel over 60 minute period |
| Confirmed Catefory I Pressure Ulcer | – | Other: Physiological measurements from heelPhysiological measurements from heel over 60 minute period |
| Suspected Deep Tissue Injury | – | Other: Physiological measurements from heelPhysiological measurements from heel over 60 minute period |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From in patient population
Key inclusion criteria (15 listed)
- Able to give consent
- Male or female
- Over the age of 18 years
- No known peripheral vascular disease
- No known tissue damage
Key exclusion criteria (12 listed)
- Presence of tissue damage or ulceration in the foot
- Known peripheral vascular disease
- Known hypersensitivity to fixation tape
- Presence of a pacemaker
- Participants unable to or refusing to give informed consent
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 |
|---|---|---|
| Physiological measurements from heelMeasurements of blood flow, tissue oxygen saturation, temperature, pressure | Other | At risk of Pressure Ulcer, Confirmed Catefory I Pressure Ulcer, Healthy volunteer, Suspected Deep Tissue Injury |
Primary outcome
Laser Doppler Flowmetry
Time frame: 20 minutes
Laser light to assess perfusion of heel
Spectrometry
Time frame: 20 minutes
Light spectrometry to assess tissue oxygen saturation of the heel
Impedance
Time frame: 5 minutes
Measurement of oedema of the heel
Temperature
Time frame: 5 minutes
Thermal image of heel to assess skin temperature
1 secondary outcome
Co-morbidities
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No. Data is anonymised
Related trials for Pressure Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
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.
Gerard Stansby, MBBS principal investigator
Newcastle upon Tyne NHS Hospitals Foundation Trust/Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
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 15 inclusion and 12 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 2 Oct 2019. 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 Kingdom. 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 Emma EF Scott (01912336161, emma.scott@nuth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laser Doppler Flowmetry (time frame: 20 minutes). The study lists 4 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 2 Oct 2019.