Actively Recruiting
Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?
Led by University of Florida · Updated on 2025-06-11
10
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of tibial fracture or fracture-dislocation with acute compartment syndrome and/or vascular injury causing loss of pulses in the leg below the knee
- Injury affects only one leg
- Anterior compartment depth of the leg less than 2.5 cm measured by ultrasound
- Willing and able to give informed consent
You will not qualify if you...
- Younger than 18 years or older than 75 years
- Skin damage, open wound, or infection over the anterior muscle area preventing NIRS sensor placement
- Anterior compartment muscle depth more than 3 cm by ultrasound
- History of fasciotomy on the affected leg
- Unable to provide informed consent personally or via legal guardian
- Cannot read or understand spoken English
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UF Health
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
S
Svetlana Chembrovich, MD
CONTACT
M
Martin S Noguera, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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