Diabetes mellitus affected 382 million adults worldwide in 2013 and is expected to increase in prevalence to 592 million people by the year 2035. Foot ulceration continues to be a major comorbidity of diabetes and afflicts as many as 25% of subjects with type 1 and 2 diabetes during their lifetime. Lower limb amputations due to poor DFU management are a global burden that is associated with a 77% 5-year mortality rate and cumulatively costs the system approximately $70,000 per patient. Effective prevention and treatment of foot ulcers can be hindered due to a lack of objective standards to quantitatively track foot health and assess treatment outcomes. The broad goal of this research is to develop Modulated Imaging, a new clinically-viable tool which provides quantitative insight into disease stage, progression and therapeutic response, into a clinically-viable tool for screening and managing diabetic foot ulcers. MI is a non-contact imaging technology that determines the in-vivo concentrations of subsurface chromophores relevant to tissue health (i.e. hemoglobin, oxygenation, edema and scattering). The goal of this proposal is to develop a user-friendly dedicated MI platform system for studying the value of MI-derived biometrics (like hemoglobin, oxygenation, and scattering) in the diabetic foot. In this Phase II program, we will build a DFU-MI device and perform three pilot studies to assess the capability of our technology to impact diabetic foot care. First, we will characterize vascular reactivity in control and feet considered ?at risk? for ulcer to determine normative MI biometrics. Second, we will study our ability to predict new wound formation in feet that are considered in ?remission? but with a >35% chance of re-ulceration. Finally, we will study lower limb perfusion changes after vascular intervention for and existing wound to assess efficacy prior to wound closure. Our Phase II research will determine the insertion point of MI technology into DFU clinical care and provide insight to future Phase III clinical study hypotheses and designs in order to build a medical imaging device with indications specific to wound prediction and healing.

Public Health Relevance

Effective prevention and treatment of foot ulcers can be hindered due to a lack of objective standards to monitor progression. The goal of this research is to develop Modulated Imaging, a new optical technology which provides quantitative insight into disease status and therapeutic response, into a clinically-viable tool for screening and managing diabetic foot ulcers.

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 #
5R44DK094625-03
Application #
9324204
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2012-04-01
Project End
2019-07-31
Budget Start
2017-08-01
Budget End
2019-07-31
Support Year
3
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Modulated Imaging, Inc.
Department
Type
DUNS #
603130928
City
Irvine
State
CA
Country
United States
Zip Code
92614