Ulcers
Conditions
Keywords
tissue oxygenation, Near infrared spectroscopy, lower extremity ulcers, ulcers, SnapshotNIR, NIRS, imaging, oxyhemoglobin, deoxyhemoglobin, hemoglobin, oxygen saturation, wound healing
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.
Interventions
DEVICENIRS 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
Sponsors
WoundCentrics LLC
Kent Imaging Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient health outcome | 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
| Measure | Time frame | Description |
|---|---|---|
| Health Economic Impact | 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 treatment plans, interventions, and financial expenses by comparing between the control and interventional groups |
Countries
United States
Outcome results
None listed