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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06512870
Status
Recruiting

Conditions

  • Compartment Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Near infrared spectroscopy (NIRS) — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Jun 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: 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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF HealthGainesvilleFlorida32610
Yury Zasimovich, MD
352-273-8954
Svetlana Chembrovich, MD
(352) 273-8954

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