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

• Conditions: Pressure Ulcer
• Interventions: Other: Physiological measurements from heel

• Registration Number: NCT04113148
• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-07-04
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-01
• Last Update Submitted: 2019-10-01
• Study First Posted: 2019-10-02
• Last Update Posted: 2019-10-02
• Primary Completion: 2019-11
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteer	Physiological measurements from heel	Physiological measurements from heel over 60 minute period
At risk of Pressure Ulcer	Physiological measurements from heel	Physiological measurements from heel over 60 minute period
Confirmed Catefory I Pressure Ulcer	Physiological measurements from heel	Physiological measurements from heel over 60 minute period
Suspected Deep Tissue Injury	Physiological measurements from heel	Physiological measurements from heel over 60 minute period

Primary Outcome Measures

Name	Time	Method
Spectrometry	20 minutes	Light spectrometry to assess tissue oxygen saturation of the heel
Laser Doppler Flowmetry	20 minutes	Laser light to assess perfusion of heel
Impedance	5 minutes	Measurement of oedema of the heel
Temperature	5 minutes	Thermal image of heel to assess skin temperature

Secondary Outcome Measures

Name	Time	Method
Co-morbidities	5 minutes	The presence of peripheral arterial disease, ischaemic heart disease, diabetes and previous pressure ulcers

Trial Locations

Locations (1)

Vascular Dept; 🇬🇧 Newcastle, Tyne And Wear, United Kingdom