Effect of NIRS-assisted Assessment on Chronic Lower Extremity and Other Chronic Non-healing Ulcers

Kent Imaging

Status: Terminated

Conditions: Ulcers

Treatments: Device: NIRS imaging in addition to SOC

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06702852

MG-NIRS-03

Details and patient eligibility

About

Investigation of the predictive value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic non-healing Ulcers

Full description

The objective of this study is to evaluate the clinical and economical effect of introduction of near-infrared spectroscopy (NIRS) in the diagnostic and treatment protocol of patients with lower extremity (LE) ulcers as well as other chronic non-healing ulcers, and to determine a positive and/or negative predictive value or range of values for NIRS correlating to patient progress and outcomes.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current patients or patients admitted to Christus Wound Care and Hyperbaric Medicine Departments between July 1, 2024, and December 31, 2024, for the treatment of lower extremity ulcers and other chronic non-healing ulcers.
• Lower extremity ulcers and chronic non-healing ulcers will be included in the study regardless of the wound/ulcer etiology. Patients may become eligible for the study at any point during their course of treatment.

Exclusion criteria

• Patients who are being treated at multiple research sites simultaneously.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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221 participants in 2 patient groups

Control

No Intervention group

Description:

The control group will receive the standard of care per the facility Standard Operating Procedures (SOP)

Intervention

Experimental group

Description:

The intervention group will receive the standard of care per the facility Standard Operating Procedures (SOP) with the addition of NIRS imaging utilizing the SnapshotNIR

Treatment:

Device: NIRS imaging in addition to SOC