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

RecruitingObservational study

Can Near Infrared Spectroscopy (NIRS) or Intramuscular Glucose Monitoring (IMGM) Detect Impaired Perfusion in the Anterior Compartment of the Leg in Patients With Tibial Fractures? "Proof of Concept" Pilot Study

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. 18 years of age to 75 years of age
2. 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
3. Unilateral injury (i.e. only one leg is affected)

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

Exclusion Criteria:

1. Younger than 18 years of age or over 75 years of age
2. Skin damage, open wound or infection at the skin overlying the anterior muscular compartment, preventing NIRS sensor placement.
3. Depth to the muscle more than 3 cm as assessed with ultrasound.
4. History of fasciotomy performed on the affected leg.
5. Inability to obtain the informed consent from the patient of legal guardian or healthcare surrogate.
6. Language barrier- Inability to read or understand spoken English

About the study

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.

What is being tested

Sponsor: University of Florida · Participants: 10 · Started: Mar 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06512870

Locations in the U.S.

FloridaUF Health, Gainesville

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.