Investigation of the Predictive Value of Near Infrared Spectroscopy in Chronic Lower Extremity and Other Chronic Non-healing Ulcers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ulcers
- Sponsor
- Kent Imaging Inc
- Enrollment
- 221
- Locations
- 1
- Primary Endpoint
- Patient health outcome
- Status
- Terminated
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Patient health outcome
Time Frame: From enrollment to closeout or 12 weeks from enrollment whichever is earlier
To evaluate the impact of the addition of NIRS to the SOP on patient health outcome by comparing between the control and interventional groups
Secondary Outcomes
- Health Economic Impact(From enrollment to closeout or 12 weeks from enrollment whichever is earlier)