Clinical trial NCT04113148: Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration
Official title: Optical Pressure Ulcer Study: Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pressure Ulcer
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From in patient population

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.

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

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

Primary outcomes:
measure: Laser Doppler Flowmetry
timeFrame: 20 minutes
measure: Spectrometry
timeFrame: 20 minutes
measure: Impedance
timeFrame: 5 minutes
measure: Temperature
timeFrame: 5 minutes
Secondary outcomes:
measure: Co-morbidities
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Vascular Dept
state: Tyne And Wear
Study officials:
affiliation: Newcastle upon Tyne NHS Hospitals Foundation Trust/Newcastle University
name: Gerard Stansby, MBBS
role: PRINCIPAL_INVESTIGATOR
References: