Irvine, CA—February 1, 2021
Modulim, the global leader in optical imaging solutions for the non-invasive assessment of tissue and vascular health, announced today the results from its latest study published in The Journal of Diabetes and Its Complications. Conducted at the podiatry clinic at Kaiser Permanente Southern California, the research evaluated the utility of spatial frequency domain imaging (SFDI) biomarkers as a quantitative ulcer risk metric for diabetic foot ulcer onset.
Multiple studies have shown that effective preventive care of diabetic foot ulcers must include risk stratification to guide early and targeted intervention. Noting that microcirculation status is a key input for risk stratification, the clinical research team lead by Dr. Suzette Lee, DPM, regional coordinating physician for Southern California Permanente Group, sought to determine if SFDI could provide a reliable, quantitative, point-of-care assessment of microcirculation status in the clinic.
The study, funded by the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), reported SFDI imaging results from 252 subjects with diabetes determined to be at various levels of risk for foot ulceration, using the American Diabetes Association (ADA) comprehensive foot examination, risk assessment and classification guide1.
First, the authors reported that the highest risk clinical patients (history of ulcers) had significantly different SFDI microcirculation biomarkers (HbT1 and StO2) compared to patients at lower clinical risk. These biomarker signatures were consistent with prior observation of arterio-venous shunting in the microcirculation due to diabetes related autonomic neuropathy.
In addition, the study reported the SFDI biomarkers were able to predict ulcerations 1 year after imaging with a sensitivity of 75% and a specificity of 69%, independent of clinical metrics. “The current methods for risk stratification suffer from inadequate sensitivity and specificity for population management,” said Amaan Mazhar, Modulim’s Chief Product Officer and principal investigator for the grant. “The lack of quantitative assessment tools makes effective prevention an expensive and difficult measure to implement. By validating quantitative SFDI biomarkers and use in a point of care setting, we now have the foundation to deploy SFDI technology to the community care setting, empowering clinicians to provide quality, cost-effective patient care at risk for lower-limb complications.”
Over 30 million patients are living with diabetes in the US and have a 25% lifetime risk of developing a diabetic foot ulcer (DFU), which can lead to amputations, increased costs, and high mortality. The cost burden to the US Healthcare system is estimated to be $17 billion dollars annually, including treatment, amputations, and hospitalizations.2, 3 Among the diabetic population today, 85% of amputations are preceded by an ulcer, which yields an average cost of $70,000 per episode4, 5. “Identification and management of patients at high risk of ulcers is critical for our patient management,” Dr. Lee explained. It was noted in the study that “this type of result has the potential to significantly reduce the economic burden associated with DFUs and their complications over a patient’s lifetime.”
“Modulim is proud to partner with Kaiser to help create value-based care programs grounded in quantitative microcirculation assessment,” said David Cuccia, Ph.D., Modulim’s CTO. “The microvasculature is a barometer for tissue and vascular health, and we believe integration of SFDI technology into the healthcare management of patients with diabetes can help them live healthier, longer lives. Our vision is that with the right partnerships, SFDI quantitative metrics can drive evidence-based and data driven solutions to prevent life altering complications due to diabetes and reduce the economic burden to the health care system.”
Link to publication: https://pubmed.ncbi.nlm.nih.gov/32522482/
- Boulton AJM, Armstrong DG, Kirsner RS, et al Comprehensive Foot Examination and Risk Assessment. Task Force report. American Diabetes Association, 2008
- Barshes, N. et al. The system of care for the diabetic foot: objectives, outcomes, and opportunities. Diabetic Foot and Ankle. 2013.
- Armstrong DG, Boulton AJM, and Bus Sicco. Diabetic foot Ulcers and Their Recurrence. NEJM 2017
- Mavrogenis AF, Megaloikonomos PD, Antoniadou T, et al. Current concepts for the evaluation and management of diabetic foot ulcers. EFORT Open Rev. 2018;3(9):513–525
- Lee C. Rogers, DPM ; Lawrence A. Lavery, DPM, MPH ; David G. Armstrong, DPM, PhD J Am Podiatr Med Assoc (2008) 98 (2): 166–168.
Modulim is a privately held medical device company founded by the inventors of SFDI at the University of California Irvine with a team dedicated to delivering powerful healthcare solutions that elevate and standardize health care delivery, while improving patient outcomes. Its mission is to deliver transformative optical solutions that help people live healthier, longer lives. Clarifi®, powered by Spatial Frequency Domain Imaging (SFDI) technology, identifies compromised circulation at the point of care through non-contact rapid microvascular assessment of tissue. Clinicians and healthcare systems are empowered by SFDI images to make proactive, data-driven decisions in a multidisciplinary care setting, to reduce lower-limb complications caused by diabetes and peripheral arterial disease. Clarifi Imaging System is an FDA cleared and CE Marked product. Modulim is backed by Pangaea Ventures, Fresenius Medical Care Ventures, Grey Sky Venture Partners, Mitsubishi Capital, Hamamatsu Photonics, The Cove Fund at UCI Applied Innovation, and Fouse KK. Clarifi is a registered trademark of Modulated Imaging (dba Modulim).
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