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Early detection of pressure ulcers in individuals with a complete spinal cord injury

Early detection of pressure ulcers in individuals with a complete spinal cord injury - Early detection of PU

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44664
Enrollment
60
Registered
2015-06-18
Start date
2015-12-14
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decubitus pressure sores Pressure ulcers

Interventions

None listed

Sponsors

Technische Universiteit Eindhoven
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Group 1 * Adult * Have a sensory and motor complete lesion, ASIA A between L1 and C4 * Lesion acquired less than 1 year ago * Possible to collect a non-contaminated urine sample (e.g. naturally controlled urination, clean intermittent catheterisation, indwelling catheter with a sample port) * Signed informed consent ;Group 2+4 * Adult * Have a sensory and motor complete lesion, ASIA A between L1 and C4 * Lesion acquired over 1 year ago. * Possible to collect a non-contaminated urine sample (e.g. naturally controlled urination, clean intermittent catheterisation, indwelling catheter with a sample port) * Signed informed consent ;Group 3 * Adult * In good health * Signed informed consent

Exclusion criteria

Exclusion criteria: All groups * Mental disability that hinders the ability to understand and comply with the informed consent * Diagnosed skin disease * Oncological patients * If a subject is unable to obtain urine samples themselves and do not have assistance. * Fever (temperature > 38*C) will lead to temporary exclusion * Have had a pressure ulcers diagnosed in the past 6 months.;Extra exclusion criteria for group 1+2+3 * Active infections at the start of the study (determined by POCT CRP) will lead to temporary exclusion * If a subject in the home situation does not have the ability to store samples at minus 20*C.

Design outcomes

Primary

MeasureTime frame
The concentration of several biomarkers in urine.

Secondary

MeasureTime frame
To determine possible causes for changes in biomarker concentration not associated with a PU.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)