Orpyx Digital Health Platform Selected for $5M NIH-Funded Clinical Trial on Diabetic Foot Ulcer Prevention
Medical Technologies announced today that its advanced digital health platform—including its proprietary sensory insoles, analytics infrastructure, and remote patient monitoring program—has been selected for use in a major new clinical trial funded by the National Institutes of Health (NIH). The study, titled WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention, will be led by the Johns Hopkins University School of Medicine in partnership with collaborators from Keck Medicine of USC and the University of Utah Spencer Fox Eccles School of Medicine. This multi-institutional effort reflects a growing recognition of the critical role digital tools can play in preventing diabetic foot ulcers (DFUs), a severe and costly complication that remains a leading cause of lower limb amputation worldwide.
The trial, supported by a $5 million R01 award from the NIH, aims to enroll 400 individuals who are at high risk for recurring DFUs. Participants will be monitored over the duration of the study to determine whether integrating continuous digital foot monitoring into routine clinical care can reduce the incidence of new ulcer development. DFUs represent one of the most challenging complications related to diabetes. They account for enormous healthcare costs, frequent hospitalizations, and profound impacts on patient quality of life. Alarmingly, more than 80% of lower extremity amputations are preceded by a diabetic foot ulcer, underscoring the need for innovative, evidence-based prevention strategies.
The WIREDUP study seeks to directly address this challenge by evaluating whether wearable sensor technology—combined with remote monitoring and timely clinical intervention—can shift the current paradigm from reactive wound care to a more proactive, preventative model. Orpyx’s digital health system is uniquely suited for this purpose. It includes specialized sensory insoles designed to collect real-time data on plantar pressure, temperature changes, and activity patterns, all of which are critical indicators associated with DFU risk. Elevated plantar pressure, for example, is a well-documented precursor to skin breakdown, while localized temperature increases can signal inflammation or early tissue damage before ulceration occurs.
Data captured by the insoles will be transmitted to Orpyx’s analytics platform, which uses advanced data processing to highlight patterns or anomalies that could indicate elevated risk. The platform is designed to synthesize complex biometric inputs and deliver actionable insights to healthcare teams. When combined with Orpyx’s structured remote monitoring program, clinicians can receive timely alerts that allow for early intervention, whether through patient education, offloading strategies, medication adjustments, or other clinical actions. The ultimate goal is to prevent the cascade of complications that often accompany DFUs and to reduce the likelihood of hospitalization, infection, and amputation.
While Orpyx is providing the full technology infrastructure for the trial, the company emphasized that all study oversight, data collection, and analysis will remain entirely under the control of the independent academic research team. This model ensures scientific integrity and reinforces the trial’s focus on generating rigorous, unbiased evidence. By partnering with leading academic institutions, the study aims to provide one of the largest and most comprehensive evaluations to date of digital foot monitoring as a preventative tool in high-risk diabetes populations.
Dr. Breanne Everett, CEO and founder of Orpyx Medical Technologies, highlighted the importance of supporting independent scientific research in advancing diabetes care. “Supporting independent, peer-reviewed research is central to advancing care for people with diabetes,” said Dr. Everett. “We are honored that our platform has been selected for use in this NIH-funded trial, which will generate high-quality evidence to inform the role of digital tools in diabetic foot ulcer prevention.” She noted that while significant advances have been made in diabetes management, DFU prevention remains a substantial unmet need. Digital technologies such as Orpyx’s sensory insoles, she added, have the potential to transform long-standing clinical challenges by enabling early detection and tailored intervention.
The burden of diabetic foot ulcers is staggering. Globally, patients with diabetes face a lifetime risk of developing a DFU as high as 25%, and recurrence rates remain extremely high even after ulcers heal. In many cases, individuals who experience one ulcer are likely to develop another within months or years. DFUs not only impact mobility and independence but also impose significant emotional, economic, and health system costs. Despite advances in wound care, outcomes have remained largely unchanged for decades, reflecting the need for innovative approaches that address the root causes of ulcer formation rather than waiting for wounds to appear.
This study represents a major step forward in translating preventive digital health tools into mainstream clinical practice. By enrolling a large and diverse patient population across multiple institutions, the trial aims to provide robust data on the real-world effectiveness of continuous foot monitoring. Researchers hope to determine not only whether the technology reduces ulcer incidence but also how it affects patient behavior, adherence, and overall care pathways. Insights from the trial could help inform new standards of care for people with diabetes, especially those who have already experienced ulceration and are therefore at greatest risk.
In addition to the clinical goals, the WIREDUP trial reflects a broader movement toward integrating wearable technologies and remote monitoring into chronic disease management. As healthcare systems increasingly embrace digital transformation, tools that enable real-time data collection and proactive intervention are becoming vital components of patient-centered care. Orpyx’s platform is part of this evolution, offering clinicians a way to extend monitoring beyond clinic walls and give patients a more empowered role in their own care.
The company’s involvement in the WIREDUP study also builds on its long-standing commitment to improving outcomes for individuals living with diabetes-related foot complications. Over the past decade, Orpyx has developed a range of technologies aimed at reducing the incidence of preventable ulcers, improving limb preservation, and lowering healthcare costs associated with diabetic foot disease. Its solutions have been used in clinical settings across North America, and the company continues to prioritize collaboration with leading researchers, clinicians, and health systems.
As the WIREDUP trial prepares to launch, anticipation is growing that the combination of wearable sensor technology, data-driven insights, and remote monitoring could fundamentally shift how clinicians manage DFU risk. With strong academic leadership from Johns Hopkins University School of Medicine and support from top-tier research partners, the study is positioned to generate meaningful evidence that could influence future guidelines and inform best practices for digital health–enabled diabetic foot care.
About Orpyx Medical Technologies Inc.
Orpyx® is a health technology company helping people with diabetes stay on their feet and preserve independence through its patented sensor-enabled smart insole system and integrated remote monitoring program. Built to detect early warning signs and prompt timely intervention, the Orpyx continuous foot monitoring solution helps improve adherence, reduce total costs, and preserve mobility and quality of life. The company partners with VA Medical Centers, health systems, and payers across North America to deliver clinically validated outcomes and cost savings at scale.
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