RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-03-01
Study Completion:2026-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06512870

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years of age to 75 years of age
  2. 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. 3. Unilateral injury (i.e. only one leg is affected)
  1. 1. Younger than 18 years of age or over 75 years of age
  2. 2. Skin damage, open wound or infection at the skin overlying the anterior muscular compartment, preventing NIRS sensor placement.
  3. 3. Depth to the muscle more than 3 cm as assessed with ultrasound.
  4. 4. History of fasciotomy performed on the affected leg.
  5. 5. Inability to obtain the informed consent from the patient of legal guardian or healthcare surrogate.
  6. 6. Language barrier- Inability to read or understand spoken English

Contacts and Locations

Study Contact

Svetlana Chembrovich, MD
CONTACT
443-760-1481
schembrovich@anest.ufl.edu
Martin S Noguera, MS
CONTACT
352-294-8294
mnoguera@ufl.edu

Study Locations (Sites)

UF Health
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01
Study Completion Date2026-11-01

Study Record Updates

Study Start Date2025-03-01
Study Completion Date2026-11-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Compartment Syndromes