Status:

UNKNOWN

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

Lead Sponsor:

Newcastle-upon-Tyne Hospitals NHS Trust

Conditions:

Pressure Ulcer

Eligibility:

All Genders

18-99 years

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 investigato...

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 i...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2019

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2020

Estimated Enrollment :

170 Patients enrolled

Trial Details

Trial ID

NCT04113148

Start Date

June 1 2019

End Date

January 1 2020

Last Update

October 2 2019

Active Locations (1)

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1

Vascular Dept

Newcastle, Tyne and Wear, United Kingdom, NE7 7DN