RecruitingNot Applicable

Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?

United States10 participantsStarted 2025-03-01

Plain-language summary

Near infrared spectroscopy (NIRS), a technique that relies on differential absorption of infrared light to provide relative estimation of tissue oxygenation, has been successfully used to monitor perfusion of various tissues, including muscle tissue of the lower extremity, however available research reports mixed success and this technology is not currently a standard of care for patients with leg fractures. The investigators propose use of NIRS technology in patients with diagnosis of tibial fracture and acute compartment syndrome to detect / document impaired perfusion of the anterior compartment of the leg, as compared to their non-broken leg. The investigators also propose measurement of intramuscular glucose level in the affected leg and compare it to a fingerstick glucose to detect relative hypoglycemia in the affected muscular compartment. If proven effective, NIRS, or IM glucose, or both techniques could be used for clinical monitoring of patients with tibial fractures at risk for acute compartment syndrome.

Who can participate

Age range

18 Years – 75 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

. 18 years of age to 75 years of age
. Diagnosis of tibial fracture or fracture-dislocation complicated by diagnosis of acute compartment syndrome AND/OR diagnosis of concomitant vascular injury with documented loss of pulses in the leg below the knee
. Unilateral injury (i.e. only one leg is affected)

Exclusion criteria

. Younger than 18 years of age or over 75 years of age
. Skin damage, open wound or infection at the skin overlying the anterior muscular compartment, preventing NIRS sensor placement.
. Depth to the muscle more than 3 cm as assessed with ultrasound.

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

Use of NIRS to detect changes in perfusion in tibial fractures with acute compartment syndrome or leg ischemia due vascular compromise.

Timeframe: 72 hours

Use of point-of-care IM glucose to document relative hypoglycemia in the anterior compartment of the affected leg as an indicator of ACS and/or tissue ischemia.

Timeframe: once, intraoperatively

Trial details

NCT IDNCT06512870

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-11-01

Contact for this trial

Svetlana Chembrovich, MD

443-760-1481 schembrovich@anest.ufl.edu

View on ClinicalTrials.gov More Compartment Syndromes trials