Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration
OPUS
Optical Pressure Ulcer Study: Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration
2 other identifiers
observational
170
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 4, 2019
CompletedFirst Posted
Study publicly available on registry
October 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedOctober 2, 2019
October 1, 2019
5 months
July 4, 2019
October 1, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Laser Doppler Flowmetry
Laser light to assess perfusion of heel
20 minutes
Spectrometry
Light spectrometry to assess tissue oxygen saturation of the heel
20 minutes
Impedance
Measurement of oedema of the heel
5 minutes
Temperature
Thermal image of heel to assess skin temperature
5 minutes
Secondary Outcomes (1)
Co-morbidities
5 minutes
Study Arms (4)
Healthy volunteer
Physiological measurements from heel over 60 minute period
At risk of Pressure Ulcer
Physiological measurements from heel over 60 minute period
Confirmed Catefory I Pressure Ulcer
Physiological measurements from heel over 60 minute period
Suspected Deep Tissue Injury
Physiological measurements from heel over 60 minute period
Interventions
Measurements of blood flow, tissue oxygen saturation, temperature, pressure
Eligibility Criteria
From in patient population
You may qualify if:
- HEALTHY VOLUNTEERS:
- Able to give consent
- Male or female
- Over the age of 18 years
- No known peripheral vascular disease
- No known tissue damage
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vascular Dept
Newcastle, Tyne and Wear, NE7 7DN, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerard Stansby, MBBS
Newcastle upon Tyne NHS Hospitals Foundation Trust/Newcastle University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2019
First Posted
October 2, 2019
Study Start
June 1, 2019
Primary Completion
November 1, 2019
Study Completion
January 1, 2020
Last Updated
October 2, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
Data is anonymised