Path Active™ for Foot Ulcer

This trial tests a digital health tool called Path Active™, which includes smart insoles and an app, to help people with diabetes monitor their risk of developing foot ulcers. The goal is to simplify foot health management at home and reduce doctor visits. The trial will compare two groups: one will receive alerts about their ulcer risk, while the other will not, though both groups will have access to features like pressure and temperature monitoring. The trial seeks participants with diabetes who have had a foot ulcer before, can walk at least 100 meters without aids, and own a smartphone. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that could enhance diabetes care.

Research has shown that Path Active™, a digital health tool for monitoring the risk of foot ulcers, is generally easy for users to handle. Although past studies have not provided specific information about negative effects, the tool is non-invasive. This means it doesn't enter the body or use medications, which typically reduces the chance of side effects.

Since the trial remains in an early phase and is not yet testing for widespread use, safety information might be limited. However, similar digital health tools have been used widely without major safety issues. It's important to note that this tool is designed to help prevent foot ulcers by assessing risk, not to treat existing ulcers with drugs or surgery.

Most treatments for diabetic foot ulcers focus on healing existing wounds, using methods like specialized dressings, pressure relief, or antibiotics. But Path Active™ is different because it proactively alerts users to the risk of developing plantar diabetic foot ulcers before they occur. This innovative approach integrates real-time notifications based on foot pressure and temperature monitoring, which can help prevent ulcers from forming in the first place. Researchers are excited about this because it shifts the focus from treatment to prevention, potentially reducing the incidence and severity of foot ulcers in diabetic patients.

Research has shown that Path Active™, a digital health tool with smart insoles, may help reduce diabetic foot ulcers (DFUs). In one study, patients using similar smart technology experienced an 86% drop in ulcer cases with regular use. This trial will compare two approaches: one group will use Path Active™ with ulcer-risk alerts enabled, while the control group will use Path Active™ with all ulcer-risk alerts disabled. Another study found that 56% of patients receiving active treatment healed completely within 12 months, compared to only 27% in the control group. These results suggest that Path Active™ could effectively monitor and lower the risk of DFUs by providing timely alerts and information to users.⁶⁷⁸⁹¹⁰