Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities (NCT03604029) | Clinical Trial Compass
UnknownNot Applicable
Evaluating the Diagnostic Performance of ACS Using NIRS in Traumatized Lower Extremities
United States300 participantsStarted 2019-01-07
Plain-language summary
This is a study intended to validate a new set of guidelines for a device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs and forearms in specific situations.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 to 65 years
. Ability to be enrolled within 12 hours of qualifying injury
. Must have at least one uninjured upper or lower extremity
. Must have a "severe leg injury" meeting one of the following anatomical locations and mechanisms of injury.
. Tibia/fibula shaft fracture
. Tibial plateau fracture (including lateral split depression, lateral depression, medial plateau, bicondylar, and bicondylar with metaphyseal extension)
. Gunshot wound to leg without tibia fracture
. Fall from more than 5-foot height
Exclusion criteria
. Application of NIRS monitoring would be an impediment to care
. Known prior injury, surgery, or disease of the lower extremity (including thigh) that alters normal circulation in the leg (including peripheral vascular disease)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute Compartment Syndrome
Timeframe: Zero to seventy two hours from enrollment.