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NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome

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Dartmouth Health

Status

Completed

Conditions

Compartment Syndrome of Lower Leg
Compartment Syndrome of Forearm
Compartment Syndromes

Treatments

Procedure: Lower extremity and/or upper extremity surgery

Study type

Observational

Funder types

Other

Identifiers

NCT05672381
STUDY02001595

Details and patient eligibility

About

This is a prospective observational study of patients with suspected Acute Compartment Syndrome. The primary objective of this work is to determine whether intensity changes associated with the NIRST signal, reflecting oxy- and deoxy-hemaglobin and water concentrations or ICG fluorescence signal, reflecting tissue perfusion, can be associated with development of Acute Compartment Syndrome and identification of at-risk soft tissue and muscle.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18 years or older

  • Clinical suspicion of acute compartment syndrome based on orthopaedic provider assessment. Clinical suspicion would be based upon the presence of one or more of these findings:

    • Pain out of proportion to visible findings
    • Escalating doses of pain medication
    • Pain with passive stretch of toes and/or fingers
    • Pallor, paresthesias, pulselessness
    • Tense soft tissues
    • High energy tibia or forearm fracture
  • Provision of informed consent

Exclusion criteria

  • History of allergy to ICG and/or iodine
  • Pregnant women or nursing mothers
  • Any patient with an open wound for whom NIRST device cannot be applied >4cm from the open wound will be excluded from NIRST imaging.

Trial design

15 participants in 2 patient groups

Lower leg Trauma
Description:
High-energy lower leg trauma at risk for Acute Compartment Syndrome
Treatment:
Procedure: Lower extremity and/or upper extremity surgery
Forearm Trauma
Description:
High-energy forearm trauma at risk for Acute Compartment Syndrome
Treatment:
Procedure: Lower extremity and/or upper extremity surgery

Trial contacts and locations

1

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Central trial contact

Devin S Mullin; Holly B Symonds

Data sourced from clinicaltrials.gov

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