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

Completed

• Conditions: Decubitus; pressure sores; pressure ulcer; 10041543

• Registration Number: NL-OMON42849
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

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

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mechanical properties of soft tissue susceptible for the onset to deep tissue<br /><br>injury. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Compare the mechanical properties of the gluteus muscles in healthy and SCI<br /><br>individuals with US and MR Elastography<br /><br>* Investigate the reproducibility of muscle mechanical properties measurements<br /><br>with both US and MR Elastography in healthy volunteers<br /><br>* Investigate the correlation of muscle mechanical properties measurements<br /><br>found with US and MR Elastography in healthy volunteers</p><br>