NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome (NCT05672381) | Clinical Trial Compass
CompletedNot Applicable
NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome
United States15 participantsStarted 2023-05-12
Plain-language summary
This is a prospective observational study of patients with suspected Acute Compartment Syndrome. The primary objective of this work is to determine whether intensity changes associated with the NIRST signal, reflecting oxy- and deoxy-hemaglobin and water concentrations or ICG fluorescence signal, reflecting tissue perfusion, can be associated with development of Acute Compartment Syndrome and identification of at-risk soft tissue and muscle.
Who can participate
Age range
18 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:
* Age 18 years or older
* Clinical suspicion of acute compartment syndrome based on orthopaedic provider assessment. Clinical suspicion would be based upon the presence of one or more of these findings:
* Pain out of proportion to visible findings
* Escalating doses of pain medication
* Pain with passive stretch of toes and/or fingers
* Pallor, paresthesias, pulselessness
* Tense soft tissues
* High energy tibia or forearm fracture
* Provision of informed consent
Exclusion Criteria:
* History of allergy to ICG and/or iodine
* Pregnant women or nursing mothers
* Any patient with an open wound for whom NIRST device cannot be applied \>4cm from the open wound will be excluded from NIRST imaging.
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
Association of NIRST or ICG measurements with development of ACS