Using real-time blood flow imaging to prevent limb loss in diabetic foot disease

Approximately one in 10 Americans has diabetes, most of whom have Type 2. Prevalence of the disease continues to rise across all age groups, lowering quality of life for many people by increasing the risk of heart disease, stroke and kidney disease.

One of the most serious and costly complications of diabetes is critical limb ischemia (CLI), a severe obstruction of blood flow to the lower limbs. When this happens, circulation to the feet becomes impaired and even minor wounds can fail to heal, leading to infection, tissue death and sometimes amputation.

Each year, more than 160,000 people with diabetes in the United States undergo lower-limb amputation, often as a downstream consequence of CLI, even though many of these outcomes could be avoided with earlier detection and revascularization or wound intervention.

While current standards of care can identify advanced vascular disease, there is a significant gap when it comes to detecting ischemia early. Tools like the ankle-brachial index (ABI) and toe pressure assessment are widely used but may be unreliable in patients with diabetes because arterial calcification and vessel stiffening can render ABI falsely normal or elevated, and toe pressures can be difficult to obtain or interpret, reducing the sensitivity of these tests for early ischemia.

Currently, most patients with diabetes receive care through their primary care physician rather than through a specialist such as an endocrinologist because of an ongoing shortage of specialists. As the gap between the number of primary care doctors and patients grows and appointment times are compressed to accommodate more patients, around 43% of patients do not receive comprehensive foot exams, which are the primary method of detecting complications.

A promising new technology

Real-time blood flow imaging is an emerging way to narrow this diagnostic gap and provide earlier, more granular insight into tissue perfusion.

By using near-infrared light and speckle contrast imaging, clinicians can visualize and quantify blood flow and volume beneath the skin in the same regions where ulcers form. Unlike traditional methods that offer single-point readings, this technology can measure multiple sites across the leg and foot, mapping distinct regions.

The ability to compare flow patterns in real time offers a new level of insight into localized ischemia that may not be visible on the surface. Near-infrared imaging has already shown promise for quantifying microvascular perfusion and ischemic burden in the foot and lower limb, suggesting it could complement pressure-based tests in peripheral arterial disease.

Similar optical systems have already demonstrated the ability to normalize blood flow and distinguish pathologic from normal states in acute stroke using portable, easy-to-use hardware, which keeps it accurate without anchoring to a specific study.

In a vascular clinic or wound care setting, these maps could complement existing diagnostic frameworks such as the wound, ischemia and foot infection classification, providing a standardized, objective measure of ischemic severity.

Beyond diagnostics, portable and easy-to-use imaging systems could bring ischemia screening to new points of care, including community clinics, primary care offices or even home-based monitoring. Because optical systems can be built from the same camera and semiconductor components used in consumer electronics, they have the potential to be substantially less expensive and more scalable than many existing vascular imaging modalities once produced at scale.

While lifestyle factors such as diet and exercise remain central to prevention, the truth is that many diabetic complications begin long before symptoms appear. Identifying those at risk of CLI earlier allows for timely referral to vascular specialists, optimization of medical therapy and initiation of wound prevention strategies.

The societal impact

The U.S. diabetic population is expected to increase 54% by the year 2030 to almost 55 million Americans, with total direct and indirect annual medical and societal costs exceeding $600 billion. 

People with diabetes who do face amputation often find that it has a dramatic effect on their quality of life, body image and self-esteem. Living with limb loss may require major adjustments to lifestyle, employment and activities of daily living. 

Amputation is also a high-cost surgery. Depending on complexity and setting, initial procedures are often reported in the range of $5,000 to $60,000. Over a lifetime, rehabilitation, prosthetics, mobility aids and follow-up doctor appointments can cost over $500,000.

This new technology has the potential to improve outcomes for millions of people, preserving their quality of life and lessening the financial burden of the disease. Accurate and early screenings have the potential to catch complications before they cause irreparable harm and cost patients thousands of dollars.

Real-time blood flow imaging is not a cure, but it represents a paradigm shift — from reacting to ulcers and amputations to proactively measuring tissue health before irreversible damage occurs. As these technologies are clinically validated and incorporated into care pathways, they may help standardize how ischemia is quantified, reduce the burden on overextended vascular labs and change the trajectory for many people living with diabetic foot disease.

Aaron Timm, Openwater CEO, has held executive leadership roles at digital health, medical device and medical imaging companies. He has led all aspects of commercial strategy, corporate development and business operations to scale start-ups into high-growth, multinational companies. Aaron has extensive experience navigating regulatory compliance, patent law and product-scale supply chain. In addition to chief executive roles at Synarc and WorldCare Clinical, Aaron has served as general counsel of both private and publicly traded companies. Aaron earned degrees from Georgetown University and Harvard Law School and is a member of the State Bar of California.