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Observational Study for Necrotizing Soft Tissue Infections (NSTI) Diagnosis

This study is looking for adults (18 and older) who are suspected of having a necrotizing soft tissue infection (NSTI), also known as "flesh-eating bacteria." NSTIs are serious infections that need quick diagnosis. Researchers will give participants a diagnostic test involving a dye called indocyanine green (ICG) and special imaging. The goal is to see if this method can reliably detect reduced blood flow in infected tissue, which could lead to faster and more accurate diagnosis of NSTI. This study aims to enroll 420 participants, but its current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will observe and collect information without assigning treatments. It plans to include 420 participants.
What's involved
You would receive a one-time, weight-appropriate dose of indocyanine green (ICG) and undergo fluorescence imaging. This process is expected to take about one day.
Compensation
Not stated in the trial record.
Follow-up
Your participation would involve measurements from enrollment until the end of fluorescence imaging, which is about one day.

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NCT06877793

Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling

Recruiting
Not specifiedAges 18+Observational
Eric R. Henderson
~420 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:Administration of indocyanine green (ICG) and fluorescence imaging

At a glance

Recruiting sites
6 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine if tissue perfusion, determined by first-pass ICG fluorescence kinetics, is reliably reduced in the setting of a necrotizing infection compared to a non-necrotizing infection.
Measured over From enrollment to the end of fluorescence imaging (about 1 day)

Conditions

Necrotizing Fascitis

Explore related trials

Necrotizing Fasciitis

Where it's being run

8 sites across 6 states
California2
Pennsylvania2
Georgia1
Michigan1
New Hampshire1
Tennessee1

Who to contact

Eric R Henderson, MD
[email protected]
603-650-5133
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥18 years.
Clinical suspicion of NSTI based on the local standard of care warranting:
Hospital admission for observation due to suspected NSTI; and/or
Soft tissue biopsy to rule in/out suspected NSTI; and/or
Surgical debridement for suspected NSTI; and/or
Specific institutional threshold criteria for triggering NSTI work-up; and
Ability to give written informed consent.

Exclusion

History of allergy to ICG and/or iodine.
Pregnant women or nursing mothers.

What this trial measures

  • Determine if tissue perfusion, determined by first-pass ICG fluorescence kinetics, is reliably reduced in the setting of a necrotizing infection compared to a non-necrotizing infection.From enrollment to the end of fluorescence imaging (about 1 day)

    We will evaluate first-pass fluorescence signal intensity changes from indocyanine green (ICG), a vascular perfusion fluorophore, in the setting of severe soft-tissue infections to determine if ICG fluorescence may be an accurate and reliable diagnostic test for differentiating life-threatening necrotizing infections from non-life-threatening non-necrotizing infections.