Skip to main content
Clinical Trials/NCT04113148
NCT04113148
Unknown
Not Applicable

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

Newcastle-upon-Tyne Hospitals NHS Trust1 site in 1 country170 target enrollmentJune 1, 2019
ConditionsPressure Ulcer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pressure Ulcer
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Enrollment
170
Locations
1
Primary Endpoint
Spectrometry
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
January 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Responsible Party
Sponsor

Eligibility Criteria

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
  • Able to give consent
  • Male or female
  • Over the age of 18 years

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
  • 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)

Outcomes

Primary Outcomes

Spectrometry

Time Frame: 20 minutes

Light spectrometry to assess tissue oxygen saturation of the heel

Laser Doppler Flowmetry

Time Frame: 20 minutes

Laser light to assess perfusion of heel

Impedance

Time Frame: 5 minutes

Measurement of oedema of the heel

Temperature

Time Frame: 5 minutes

Thermal image of heel to assess skin temperature

Secondary Outcomes

  • Co-morbidities(5 minutes)

Study Sites (1)

Loading locations...

Similar Trials