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Smartphone-based optical scanner to physiologically assess diabetic foot ulcers

Award Number: R01EB033413
ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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Smartphone-based optical scanner to physiologically assess diabetic foot ulcers - One in three people with diabetes mellitus is at risk of diabetic foot ulcers (DFUs), with over 10% amputated. The current global pandemic has driven a significant change in healthcare delivery and disrupted DFU care and limb preservation, leaving many patients with limited or no clinical care. Clinicians must adopt a paradigm shift from the hospital and clinic care to community-based point-of-care (POC) - to best triage chronic DFU cases that are high-risk lesions requiring clinical care or hospitalization. There is an unmet clinical need for smart health assessment tools for POC treatment of patients with DFUs onsite, where no wound care expertise is available. Smartphone technologies for wound care are limited to 2D/3D wound image analysis for size/depth. They are insufficient as stand-alone tools to assess and triage high-risk DFU lesions without wound expertise onsite. Hence, additional clinical assessments (e.g., the extent of oxygen supply to wound) are required during POC of DFUs onsite. Oxygenation measurements provide a sub-clinical physiological assessment that complements clinical visual assessment. We recently developed a smartphone-based NIR imaging approach or SmartPhone Oxygenation Tool (SPOT) to obtain visual tissue oxygenation measurements in wounds. Systematic assessment of the skin tone and wound characteristics is critical during physiological imaging and has not been investigated to date. Hence, our objective is to develop and validate a smartphone-based imaging approach (or Smart Scanner) capable of visual and physiological analysis of DFUs across the spectrum of skin tones and wound features via automated machine learning (ML) algorithms. Developing a smartphone-based optical device via integration of existing NIR imaging technology, but towards smart health platform for physiological assessment of DFUs, while accounting for varying skin colors and wound types using ML algorithms is innovative. The specific aims are: (i) Account for the effect of skin tones on oxygenation measurements by applying light propagation models and machine learning algorithms and validate via phantom and in-vivo studies. (ii) Analyze tissue curvatures and account for depth variations in-vivo oxygenation maps via studies on control subjects (~15 cases). (iii) Differentiate wound tissue types and validate physiological imaging using the SPOT device via DFU studies (~25 cases). The expected outcomes are: (i) Develop our Smart Scanner (SPOT device + app) to obtain accurate tissue oxygenation maps across different skin tones and wound tissue types; (ii) Validate our SPOT device to differentiate DFUs with high-risk lesions that require clinical care, from low-risk cases. Incidence of DFUs and related amputation rates differ across people of different skin tones. In the long term, SPOT can be used as a smart health tool to pre-screen or triage DFUs with high-risk lesions to clinical care and thus minimize potential amputations in people with any skin tone.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2027 ( Subtotal = -$516,512 )
2027	2025	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	4	10/28/2026	NON-COMPETING CONTINUATION	-$516,512
														Subtotal = -$516,512

Issue Date FY: 2025 ( Subtotal = $539,012 )
2025	2025	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	4	6/25/2025	NON-COMPETING CONTINUATION	$539,012
														Subtotal = $539,012

Issue Date FY: 2024 ( Subtotal = $531,790 )
2024	2024	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	3	5/30/2024	NON-COMPETING CONTINUATION	$531,790
														Subtotal = $531,790

Issue Date FY: 2023 ( Subtotal = $517,729 )
2023	2023	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	2	5/24/2023	NON-COMPETING CONTINUATION	$517,729
														Subtotal = $517,729

Issue Date FY: 2022 ( Subtotal = $520,575 )
2022	2022	FLORIDA INTERNATIONAL UNIVERSITY	11200 SW 8TH ST	MIAMI	FL	33199	MIAMI-DADE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	8/9/2022	NEW	$520,575
														Subtotal = $520,575

Grand Total All Awards = $1,592,594

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Smartphone-based optical scanner to physiologically assess diabetic foot ulcers

Award Number: R01EB033413

ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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