Status:
RECRUITING
Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?
Lead Sponsor:
University of Florida
Conditions:
Compartment Syndromes
Eligibility:
All Genders
18-75 years
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 perf...
Detailed Description
Inclusion criteria: * Patient's age: 18 - 75 years old * Diagnosis of tibial fracture or fracture-dislocation with diagnosis of acute compartment syndrome AND/OR diagnosis of concomitant vascular inj...
Eligibility Criteria
Inclusion
- 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)
- 5\) Depth of anterior compartment of the leg \< 2.5 cm (as measured by ultrasound) 6) Willing to consent to the study
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06512870
Start Date
March 1 2025
End Date
November 1 2026
Last Update
June 11 2025
Active Locations (1)
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1
UF Health
Gainesville, Florida, United States, 32610