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Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration

Optical Pressure Ulcer Study: Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04113148
Acronym
OPUS
Enrollment
170
Registered
2019-10-02
Start date
2019-06-01
Completion date
2020-01-31
Last updated
2019-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

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.

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.

Interventions

OTHERPhysiological measurements from heel

Measurements of blood flow, tissue oxygen saturation, temperature, pressure

Sponsors

Newcastle-upon-Tyne Hospitals NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Laser Doppler Flowmetry20 minutesLaser light to assess perfusion of heel
Spectrometry20 minutesLight spectrometry to assess tissue oxygen saturation of the heel
Impedance5 minutesMeasurement of oedema of the heel
Temperature5 minutesThermal image of heel to assess skin temperature

Secondary

MeasureTime frameDescription
Co-morbidities5 minutesThe presence of peripheral arterial disease, ischaemic heart disease, diabetes and previous pressure ulcers

Countries

United Kingdom

Contacts

Primary ContactEmma EF Scott
emma.scott@nuth.nhs.uk01912336161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026