Recruiting

NIRS

Sponsor:

University of Florida

Code:

NCT06512870

Conditions

Compartment Syndromes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Near infrared spectroscopy (NIRS)

Study Details

Brief 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.

Conditions

Compartment Syndromes

Study ID

NCT06512870

Start date

Mar 1, 2025

Status verified date

Jun, 2025

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

Known ACS

Patients, aged 18 to 75 years, with diagnosis of unilateral tibial fracture, complicated by Acute Compartment syndrome and/or acute vascular compromise (leg ischemia, absent pulses below the knee), as diagnosed and confirmed by ED physician, orthopedic surgeon and/or vascular surgeon. Only patients with depth to anterior compartment <2.5 cm as measured by the ultrasound will be enrolled.

Interventions

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.

Primary outcome measure

  • Use of NIRS to detect changes in perfusion in tibial fractures with acute compartment syndrome or leg ischemia due vascular compromise. [ Time Frame: 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. [ Time Frame: once, intraoperatively ]

Central Contacts and Locations

Central contacts

Svetlana Chembrovich, MD

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

Martin S Noguera, MS

352-294-8294mnoguera@ufl.edu

Locations

UF Health

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Yury Zasimovich, MD

352-273-8954YZasimovich@anest.ufl.edu

Svetlana Chembrovich, MD

(352) 273-8954SChembrovich@anest.ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Keywords

  • ACS (Acute compartment syndrome)
  • NIRS (near infrared spectroscopy)
  • IM (intramuscular) glucose

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-06-11.