Investigation of the predictive value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic non-healing Ulcers
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
221
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
Christus Santa Rosa Wound Care and Hyperbaric Center
New Braunfels, Texas, United States
Christus Santa Rosa Wound Care and Hyperbaric Center
San Antonio, Texas, United States
Christus Santa Rosa Wound Care and Hyperbaric Center
San Antonio, Texas, United States
Christus Santa Rosa Wound Care and Hyperbaric Center
San Marcos, Texas, United States
Patient health outcome
To evaluate the impact of the addition of NIRS to the SOP on patient health outcome by comparing between the control and interventional groups
Time frame: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
Health Economic Impact
To evaluate the impact of the addition of NIRS to the SOP on treatment plans, interventions, and financial expenses by comparing between the control and interventional groups
Time frame: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.