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NCT06512870 · ClinicalTrials.gov registry record

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

A clinical trial of Compartment Syndromes, sponsored by University of Florida.

Recruiting
Registry status
10
Enrollment target
1
Study location

NCT06512870: Recruiting study of Compartment Syndromes, sponsored by University of Florida.

NCT06512870 is a study of Compartment Syndromes that is actively recruiting participants, run by University of Florida. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06512870, a study of Compartment Syndromes, is actively recruiting participants, sponsored by University of Florida.

RECRUITING
Registry status
10 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

NIRS sensors will be applied to the skin overlying anterior compartment of the injuries and uninjured legs. Uninjured leg will serve as a control leg. Readings from both legs will be recorded continuously until patient enters OR for emergent surgery. At that point NIRS sensor will be removed to allow skin prep for surgical procedure. NIRS sensor will be re-applied to the skin at the completion of the surgery before leg is wrapped with the dressing. Monitoring of both extremities will be continue

Conditions Studied

Interventions

  • DIAGNOSTIC_TEST Near infrared spectroscopy (NIRS)

Study Locations (1)

Florida

  • UF Health - Gainesville

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2025-03-01
Est. Completion 2026-11-01
University of Florida

1,106 total trials

What NCT06512870 shows while recruiting

NCT06512870 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.

The record links to 1 condition, with Compartment Syndromes appearing as the primary indexed condition, and to 1 intervention - of which Near infrared spectroscopy (NIRS) is the first listed.

NCT06512870 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT06512870 about?

NCT06512870 is a clinical study titled "Can Near-Infrared Spectroscopy (NIRS) or Intramuscular Glucose Levels Detect Impaired Leg Compartment' Perfusion?". 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...

What is the current status of trial NCT06512870?

This trial is currently recruiting. The enrollment target is 10 participants. The study started on 2025-03-01. Estimated completion is 2026-11-01.

What conditions does trial NCT06512870 study?

This clinical trial studies the following conditions: Compartment Syndromes.

What interventions are being tested in trial NCT06512870?

The interventions under investigation include: Near infrared spectroscopy (NIRS) (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT06512870?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06512870 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06512870, the US trial registry maintained by the National Library of Medicine. NCT06512870 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.