Elastography of soft tissue under high risk for deep tissue injury type of pressure ulcers

Elastography of soft tissue under high risk for deep tissue injury type of pressure ulcers - PrU-SCI-MRE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42849

Enrollment

Registered

2016-05-04

Start date

2017-04-01

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 ulcer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * 18 years of age or older * The capacity to understand the patient information sheet and the ability to provide written informed consent.;Healthy controls (group 2) * will be matched in adapted BMI (adapted in scale to match Spinal Cord Injured in equivalent way), sex and age with spinal cord subjects in group 3 of this study.;Spinal Cord Injured group (group 3): * Lesion of lower than vertebra C5. People with higher level lesions suffer from respiratory problems and need external ventilators. These ventilators are not MR compatible. * Lesion acquired three months ago and longer. People with a more recent Spinal Cord Injury are in spinal shock period and still in rehabilitation.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Standard contraindications to MR imaging (e.g. cardiac pacemaker, cochlear implant, claustrophobia, pregnancy). SCI group (group 3): In case of known MR compatible implants and/or pump in body: extra check will be performed to verify specific implant with Reference Manual for Magnetic Resonance Safety, Implants, and Devices. If check is negative, subject is excluded. * Waist / Shoulder width larger than 70 cm (diameter of MR scanner) * Suffer from a current pressure ulcer. * Medical history with respect to muscular diseases

Design outcomes

Primary

Measure	Time frame
Mechanical properties of soft tissue susceptible for the onset to deep tissue injury.	—

Secondary

Measure	Time frame
* Compare the mechanical properties of the gluteus muscles in healthy and SCI individuals with US and MR Elastography * Investigate the reproducibility of muscle mechanical properties measurements with both US and MR Elastography in healthy volunteers * Investigate the correlation of muscle mechanical properties measurements found with US and MR Elastography in healthy volunteers	—

Countries

Netherlands

Outcome results