Near-infrared sensors and intramuscular glucose checks to detect poor blood flow in a fractured leg
Official title: 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
Run by University of Florida · NCT06512870 · Data updated 2026-11-12
This study tests whether skin NIRS sensors and a muscle glucose measurement can detect reduced perfusion in adults with a tibial fracture and suspected compartment problems.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | November 1, 2026 |
| Registry record updated | June 11, 2025 |
| Trial ID | NCT06512870 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with a unilateral tibial fracture or fracture-dislocation complicated by acute compartment syndrome or documented loss of distal pulses, and with an anterior compartment depth under 2.5 cm, are ideal candidates.
✕Probably not a fit
People with deeper anterior compartments (>2.5–3 cm), open skin wounds over the compartment, prior fasciotomy on the affected leg, bilateral injuries, inability to consent, or who are not treated at the study site are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study enrolling adults with a unilateral tibial fracture and clinical or vascular signs of acute compartment syndrome. Bedside ultrasound is used to confirm the anterior compartment is shallow enough (<2.5 cm) for NIRS sensor placement, after which sensors are applied to the injured and the opposite uninjured leg for continuous monitoring until surgery. Investigators will also measure intramuscular glucose in the injured compartment and compare it to a fingerstick glucose to look for relative compartment hypoglycemia. Data are collected at UF Health (Gainesville) on a small cohort of about 7–10 patients to compare injured versus uninjured limb readings.
Why it matters
Potential benefit: If successful, these noninvasive or minimally invasive techniques could allow earlier detection of impaired leg perfusion and help guide timely surgical decisions to prevent muscle and nerve damage.
How similar studies have gone: NIRS has been used previously to monitor limb perfusion with mixed success and is not standard of care, while intramuscular glucose monitoring for compartment hypoperfusion is relatively novel and less well studied.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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UF Health
Gainesville, Florida, United States Recruiting
Study contacts
- Study coordinator: Svetlana Chembrovich, MD
- Email: schembrovich@anest.ufl.edu
- Phone: 443-760-1481
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.