NCT06702852

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

Investigation of the Predictive Value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic Non-healing Ulcers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Kent Imaging Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ulcers

Interventions

Type	Name	Description
DEVICE	NIRS imaging in addition to SOC	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

Timeline

• Start date: 2024-07-22
• Primary completion: 2025-01-31
• Completion: 2025-02-25
• First posted: 2024-11-25
• Last updated: 2025-05-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study