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

Pressure Ulcer Clinical Trial

— OPUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04113148
• Other study ID #: FO18022
• Secondary ID: 8779
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: January 2020

Study information

• Verified date: October 2019
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: Emma EF Scott
• Phone: 01912336161
• Email: emma.scott[@]nuth.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: January 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer

Intervention

Other:
• Physiological measurements from heel
Measurements of blood flow, tissue oxygen saturation, temperature, pressure

Locations

Country	Name	City	State
United Kingdom	Vascular Dept	Newcastle	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laser Doppler Flowmetry	Laser light to assess perfusion of heel	20 minutes
Primary	Spectrometry	Light spectrometry to assess tissue oxygen saturation of the heel	20 minutes
Primary	Impedance	Measurement of oedema of the heel	5 minutes
Primary	Temperature	Thermal image of heel to assess skin temperature	5 minutes
Secondary	Co-morbidities	The presence of peripheral arterial disease, ischaemic heart disease, diabetes and previous pressure ulcers	5 minutes