Alternating Pressure Overlay on Weight Bearing Tissue Tolerance in People With Spinal Cord Injury

Completed · Not applicable

Conditions studied: Spinal Cord Injuries, Pressure Ulcer

In brief

The purpose of this study is to test if the newly-developed Dabir alternating pressure (AP) overlay could be beneficial to preventing skin damage during daily activities, such as lying in bed. Specifically, the study is being done to test if the Dabir AP overlay could be used to increase skin tolerance when lying in bed for an extended period of time (40 minutes), including reducing pressure and increasing skin blood flow (amount of blood supply to oxygen and nutrients to skin) as compared to regular operation room (OR) overlay. A total of 20 participants with spinal cord injury will be recruited. Subjects will undergo study procedures including: AP and Control protocols. Skin blood flow and interface pressure will be collected non-invasively (from outside the body) during both protocols. During AP protocols, subject will be asked to lie on side (10 min), on back on AP overlay (40 min), on side (30 min), on back on OR overlay (40 min), and on side (10 min). During Control protocol, subject will be asked to lie on side (10 min), on back on OR overlay (40 min), and on side (10 min). Subject will then proceed to vascular control measures, including: non-invasive skin blood flow and tissue oxygen measurements with mild heating and electrical stimulation. Findings from this study will help us understand the effectiveness of the AP overlay on skin blood flow response during prolonged lying in bed.

Key facts

Study ID

NCT03317288

Run by

University of Illinois at Chicago

People needed

15

Starts

2017-05-12

Expected to finish

2019-03-31

Last updated by the study team

2021-06-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• have had spinal cord injury for more than one year
• have injury level at T10 or above
• not ambulatory and use a wheelchair for mobility
• none smokers or able to refrain from smoking four hours prior to and during the study

You may not qualify if…

• current pressure ulcer
• history of diabetes mellitus
• history of cardiovascular diseases
• history of hypertension
• history of pulmonary diseases
• pregnant women (based on a positive pregnancy test)
• Non-English speakers

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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