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

Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT04113148
Collaborator
(none)
170
Enrollment
1
Location
7
Anticipated Duration (Months)
24.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
170 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Optical Pressure Ulcer Study: Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration
Actual Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Laser Doppler Flowmetry [20 minutes]

    Laser light to assess perfusion of heel

  2. Spectrometry [20 minutes]

    Light spectrometry to assess tissue oxygen saturation of the heel

  3. Impedance [5 minutes]

    Measurement of oedema of the heel

  4. Temperature [5 minutes]

    Thermal image of heel to assess skin temperature

Secondary Outcome Measures

  1. Co-morbidities [5 minutes]

    The presence of peripheral arterial disease, ischaemic heart disease, diabetes and previous pressure ulcers

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vascular Dept Newcastle Tyne And Wear United Kingdom NE7 7DN

Sponsors and Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT04113148
Other Study ID Numbers:
  • FO18022
  • 8779
First Posted:
Oct 2, 2019
Last Update Posted:
Oct 2, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pressure Ulcer

Study Results

No Results Posted as of Oct 2, 2019