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

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.

Study Overview

• Status: Unknown
• Conditions: Pressure Ulcer
• Intervention / Treatment: Other: Physiological measurements from heel

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 Type: Observational
• Enrollment (Anticipated): 170

Contacts and Locations

• Study Contact: Name: Emma EF Scott; Phone Number: 01912336161; Email: emma.scott@nuth.nhs.uk

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle, Tyne And Wear, United Kingdom, NE7 7DN
      • Recruiting
      • Vascular Dept
      • Contact: Emma EF Scott, MBChB; Phone Number: 01912336161; Email: emma.scott@nuth.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From in patient population

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteer; Physiological measurements from heel over 60 minute period	Other: Physiological measurements from heel; Measurements of blood flow, tissue oxygen saturation, temperature, pressure
At risk of Pressure Ulcer; Physiological measurements from heel over 60 minute period	Other: Physiological measurements from heel; Measurements of blood flow, tissue oxygen saturation, temperature, pressure
Confirmed Catefory I Pressure Ulcer; Physiological measurements from heel over 60 minute period	Other: Physiological measurements from heel; Measurements of blood flow, tissue oxygen saturation, temperature, pressure
Suspected Deep Tissue Injury; Physiological measurements from heel over 60 minute period	Other: Physiological measurements from heel; Measurements of blood flow, tissue oxygen saturation, temperature, pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-morbidities	The presence of peripheral arterial disease, ischaemic heart disease, diabetes and previous pressure ulcers	5 minutes

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Investigators: Principal Investigator: Gerard Stansby, MBBS, Newcastle upon Tyne NHS Hospitals Foundation Trust/Newcastle University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: FO18022; 8779 (The Newcastle upon Tyne Hospitals NHS FT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data is anonymised

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No