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

Recruiting now

Conditions studied: Compartment Syndromes

In brief

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.

Key facts

Study ID

NCT06512870

Run by

University of Florida

People needed

10

Starts

2025-03-01

Expected to finish

2026-11-01

Last updated by the study team

2025-06-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Depth of anterior compartment of the leg < 2.5 cm (as measured by ultrasound) 6) Willing to consent to the study

You may not qualify if…

• 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.
• History of fasciotomy performed on the affected leg.
• Inability to obtain the informed consent from the patient of legal guardian or healthcare surrogate.
• Language barrier- Inability to read or understand spoken English

Where it is running

• UF Health — Gainesville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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