DFIS Eden Medical, Inc. is pleased to submit this revised Phase 2 SBIR proposal to develop the infrared "Diabetic Foot Imaging Scanner (DFIS)" to demonstrate the ability to capture dynamic thermal imagery and identify hot spots associated with repetitive stress. Diabetic foot wounds are common, complex and costly. Foot areas that are likely to ulcerate are associated with increased local skin temperature due to inflammation and enzymatic autolysis of tissue. Inflammation is characterized by the cardinal signs of: degree of redness, swelling, and heat. The key focus of DFIS imaging is to provide the capability to quantify all three signs of inflammation and identify pathological changes before they result in ulceration. The key goals of the proposed Phase 2 project are to: 1) to demonstrate the ability to capture dynamic thermal imagery of the feet, identify hot spots and inflammatory patterns in patients with diabetes;2) to assess the quantification of wound healing using wound inflammatory index (Wii), a thermal index for diabetic foot wounds;3) to associate the temporal behavior of Wii (quantified during wound healing) with 4 degree F home monitoring criteria for temperature differences between contra lateral sites on both feet during risk assessment phase with the intent to reduce ulceration risk.

Public Health Relevance

To develop a point-of-care infrared imaging system that scans around the foot of a diabetic patient to assess and associate patterns of inflammation to reduce risk of ulceration.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DK083782-02A1
Application #
8393778
Study Section
Special Emphasis Panel (ZRG1-SBIB-T (10))
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2009-07-01
Project End
2015-08-31
Budget Start
2012-09-01
Budget End
2013-08-31
Support Year
2
Fiscal Year
2012
Total Cost
$672,504
Indirect Cost
Name
Eden Medical, Inc.
Department
Type
DUNS #
102517211
City
Howard Lake
State
MN
Country
United States
Zip Code
55349