By Clinical Research News Staff 

June 4, 2025 | California Institute of Technology researchers have successfully transitioned their innovative "smart bandage" technology from preclinical animal studies to human clinical testing, marking a significant milestone in the development of real-time wound monitoring systems for chronic wound management. 

The clinical study represents the first time that a smart bandage system has been tested in human patients, with 20 participants enrolled to evaluate the iCares device's performance in monitoring diabetic foot ulcers and venous leg wounds. These wound types were specifically chosen as they represent two of the most common and challenging chronic wound conditions encountered in clinical practice. 

The human trial demonstrated that the smart bandage could detect critical biomarkers including nitric oxide, hydrogen peroxide, and oxygen levels one to three days before patients experienced clinical symptoms. This early detection capability represents a potentially transformative advance in wound care management, where early intervention can prevent complications and improve healing outcomes. 

Clinical Performance Validation 

A key achievement of the human study was validating the device's machine learning algorithm against expert clinical assessment. The artificial intelligence component successfully classified wound severity and healing potential with accuracy comparable to experienced clinicians, suggesting the technology could provide objective, standardized wound assessment capabilities. 

The clinical trial specifically focused on evaluating the device's ability to provide real-time monitoring of wound biomarkers that indicate inflammation, infection risk, and healing status. By continuously sampling fresh wound fluid through an innovative microfluidic system, the bandage provided clinicians with objective data to support treatment decisions. 

Translation from Preclinical Research 

The human study builds on earlier preclinical work that first introduced the smart bandage concept in animal models two years ago. The original research, published in Science Advances, demonstrated the feasibility of combining wound sensing with therapeutic delivery in a rodent model. However, the transition to human testing required significant technological refinements and safety validations. 

Key improvements made for human clinical use included the development of continuous wound fluid sampling capabilities and enhanced biocompatibility of materials in direct contact with human tissue. The research team also integrated more sophisticated data processing algorithms to translate sensor readings into clinically actionable information. 

Ongoing Clinical Development 

Wei Gao and his team at Caltech are currently continuing the small-scale clinical study while preparing for expanded clinical trials in larger patient populations. The researchers are actively seeking funding support from both the National Institutes of Health and the Defense Advanced Research Projects Agency to advance the technology through more comprehensive clinical testing phases. 

The next phase of clinical development will likely focus on demonstrating clinical outcomes improvement, cost-effectiveness, and scalability for broader patient populations. The research team is particularly interested in expanding testing to include other chronic wound types, such as burn wounds that require extended management periods. 

For more details, see Deborah Borfitz’s full story at Diagnostics World News.