SBIR-STTR Award

Diabetic foot ulcers (DFU) are associated with significant morbidity and mortality, with a 2.5x higher risk of 5-year mortality compared to diabetic patients without DFUs [3, 4]. The reason behind these dramatic statistics is tied to the lack of objective metrics for monitoring wound progress or deteriorating conditions. Assessment of functional perfusion is one of the biggest unmet needs for predicting wound healing. Current clinical practices still rely heavily on visual observation and clinical examination of the wound, an approach in which successful prediction of healing or amputation level survival is poor even among very experienced clinicians. The proposed innovative solution will complement the current standards of care for the characterization of DFUs by providing objective metrics and will provide details that can be missed during routine visual inspections and clinical assessments only. This solution will allow the clinician to select an appropriate management strategy for the specific case by providing clear images relative to potentially compromised circulation. The aim of the herein proposed work is to provide a three-dimensional hemodynamic map of the imaged DFU and surrounding tissue, with a controllable ?1 mm depth resolution over a depth from 0 to 0.5 cm to assess different degrees of microcirculatory perfusion and hemodynamics. This approach will provide objective and immediate assessment of DFU and surgical wound healing potential and will help clinicians make more accurate and faster treatment decisions. In complex cases, it will help surgeons select a level amputation that will still be able to heal, reducing the number of surgeries and the length of hospitalizations. We call this system NIR-LITH (Near InfraRed Layered Imaging of Tissue Hemodynamics). The system herein proposed leverages a non-contact optical- based system for tissue viability assessment, previously developed at Vivonics, to provide objective metrics about tissue viability to surgeons during debridement procedures. In order to achieve this overarching goal, the following specific aims have been proposed: ? Aim 1: Enhance first generation prototype to improve depth discrimination capabilities. Controllable depth imaging capabilities (0-0.5cm) for tissue layers discrimination (?1 mm) is the goal of this task. ? Aim 2: Develop algorithm for depth discrimination and phantom testing and characterization. ? Aim 3: System evaluation: thirty DFU patients in collaboration with Dr. L. Lavery at the University of Texas Southwestern Medical Center (UTSW) will be recruited for this task and gold standard analysis will comparted against the NIR-LITH results.

Public Health Relevance Statement:
Project Narrative Diabetic foot ulcers (DFUs) have been associated with several risks' factors (vascular disease, neuropathy etc.) and it has been shown that patients with DFU must bear the high socioeconomic burden associated with the complications and management of DFUs. Vivonics is proposing to develop an optical-based system that will allow real-time DFU and wound healing assessment in addition to providing clinicians with physiological information that is not visible to the human eye, thus improving patients outcome.

Project Terms:
Algorithms; Amputation; Regio tarsalis; Ankle; Biopsy; Blood Vessels; vascular; Calibration; Classification; Systematics; Color; Complement; Complement Proteins; Confidence Intervals; Debridement; Diagnosis; Discrimination; Cognitive Discrimination; Dyes; Coloring Agents; Edema; Dropsy; Hydrops; Eye; Eyeball; Goals; Medicare; Health Insurance for Aged and Disabled, Title 18; Health Insurance for Disabled Title 18; Title 18; health insurance for disabled; hemodynamics; Hospitalization; Hospital Admission; Human; Modern Man; image reconstruction; image construction; image generation; In Vitro; indexing; Infection; Light; Photoradiation; Manuals; Maps; Medical Staff; Methods; Morbidity - disease rate; Morbidity; mortality; Optics; optical; Oxygen; O element; O2 element; Patients; Perfusion; Physical Examination; Medical Inspection; physical examinations; pressure; Pus; Risk Factors; ROC Curve; ROC Analyses; receiver operating characteristic analyses; receiver operating characteristic curve; Sensitivity and Specificity; statistics; Swelling; Technology; Testing; Texas; Time; Tissues; Body Tissues; Toes; Ulcer; Ulceration; Universities; Vascular Diseases; Vascular Disorder; blood vessel disorder; vascular dysfunction; vasculopathy; Work; wound healing; Wound Repair; wound resolution; Generations; Imaging Techniques; Imaging Procedures; Imaging Technics; Measures; Caring; improved; Procedures; Surface; Penetration; Phase; Physiologic; Physiological; Evaluation; Visual; Individual; Measurement; Collaborations; Redness; Surgical wound; tool; Knowledge; programs; Physiologic pulse; Pulse; Complex; human tissue; Neuropathy; neuropathic; Source; Techniques; System; 3-Dimensional; 3-D; 3D; three dimensional; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; interest; Medical center; Surgeon; experience; Performance; polarized light; skills; Deterioration; Sampling; Property; portability; Intervention; Intervention Strategies; interventional strategy; Skin; Length; Tissue Viability; Diabetic Foot Ulcer; diabetic foot wound; Data; Economic Burden; Resolution; resolutions; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; patient oriented outcomes; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Process; socioeconomics; socio-economic; socio-economically; socioeconomically; Image; imaging; cost; healing; reconstruction; designing; design; Clinical assessments; diabetic management; diabetes management; Outcome; tissue wound; wounding; wounds; wound; Trauma; innovate; innovative; innovation; data acquisitions; data acquisition; prototype; high risk; bio-markers; biologic marker; biomarker; Biological Markers; diabetic patient; clinical practice; operations; operation; noninvasive imaging; non-invasive imaging; spectral image; spectral imagery; spectrum image; spectrum imagery; spectrograph; imaging system; chronic skin wound; chronic wound; Tissue imaging; imaging based approach; imaging approach; imaging capabilities; recruit; Injections; algorithm development; clinical exam; clinical examination; wound assessment; wound monitoring; wound care; treat wound; wound management; wound therapeutics; wound therapy; wound treatment; Circulation