Integrating Multispectral Near-infrared Spectroscopy and Thermography Imaging in the Management of Diabetic Foot Ulcers and Venous Leg Ulcers with Skin Substitutes

Introduction: Diabetic Foot Ulcers (DFUs) and Venous Leg Ul- cers (VLUs) represent significant healthcare challenges in the United States, exacerbated by demographic shifts such as an aging population and increasing rates of chronic diseases like diabetes and obesity. Skin substitutes have become a crucial component of treatment strategies for these wounds, driven by increasing evidence supporting their efficacy. In response to evolving clinical needs, recent Local Coverage Determina- tions (LCDs) have broadened the scope of acceptable vascular assess- ment methods to include tissue oxygenation measurements, comple- menting traditional techniques. This case study examines the integration of multispectral near-infrared spectroscopy (NIRS) to assess tissue oxygenation as part of a comprehensive approach to managing patients with lower extremity ulcers undergoing advanced treatment (AT) using skin substitutes. Methods: A handheld, FDA 510(k)-cleared NIRS and thermal imaging device* was used to measure tissue oxygenation and skin surface tem- perature. Wound images were taken at various stages: pre- and post-de- bridement during the four-week standard of care (SOC) treatment peri- od, before the first skin substitute application, and after each subsequent application (pre- and post-debridement, prior to placement). The case series involved four patients, and the key parameters of interest were wound size reduction and changes in tissue oxygenation with SOC and skin substitute application treatments. Results: The integration of NIRS and thermography imaging, alongside wound size measurements, enabled comprehensive, objective docu- mentation of wound progression. Tissue oxygenation levels confirmed sufficient perfusion necessary for wound healing, while thermography re-confirmed the absence of infection prior to skin substitute application. These combined technologies streamlined clinical workflows and provid- ed the objective data necessary to meet the medical necessity criteria for skin substitute therapy. Discussion: Non-invasive measurements of tissue oxygenation, in conjunction with skin surface temperature assessment, provide real-time insights that help predict treatment outcomes, guide clinical deci- sion-making, and ensure timely access to advanced therapies like skin substitutes. These technologies enhance clinical workflows by simplifying documentation for insurance coverage and reimbursement. Ultimately, the integration of NIRS imaging into wound care protocols not only im- proves patient outcomes but also expedites treatment access and reduces the administrative burden on healthcare providers.