Wearable Insoles for Diabetic Foot Ulcers

(WIREDUP Trial)

This trial tests special insoles designed to help prevent foot ulcers in people with diabetes. The goal is to determine if these insoles, used alongside standard care, can reduce foot sores and improve quality of life. Participants must have diabetes with a previously healed foot ulcer and be able to walk at least 30 steps, with or without a cane or walker. The study aims to assess the effectiveness and ease of use of the insoles for those at high risk of foot problems. As an unphased trial, it offers participants the chance to contribute to important research that could enhance diabetic foot care for many.

Research has shown that the Orpyx Sensory Insole System is generally easy for patients to use. Studies have found that these insoles effectively lower the chances of diabetic foot ulcers recurring, without causing major side effects. In one study, patients using the Orpyx insoles experienced a 71% reduction in foot ulcers. This suggests that the insoles are both effective and safe for preventing foot problems in people with diabetes. Overall, reports of serious negative effects have not emerged, making the insoles a promising choice for those at high risk of developing foot ulcers.¹²³⁴⁵

Researchers are excited about the Orpyx Sensory Insole System because it offers a unique approach to managing diabetic foot ulcers. Unlike traditional treatments like wound dressings and offloading shoes, this system uses advanced sensor technology embedded in wearable insoles. These sensors provide real-time feedback to patients, helping them adjust their foot pressure and reduce the risk of ulcers developing or worsening. This proactive method empowers patients to take control of their foot health, potentially reducing the need for more invasive treatments down the line.

Research has shown that the Orpyx Sensory Insole System, which participants in this trial will use, can significantly reduce diabetic foot ulcers. In one study, individuals who wore these insoles for more than 4.5 hours daily experienced an 86% decrease in recurring foot ulcers. Another study demonstrated a 71% reduction in new ulcers for those using the insoles. These insoles track foot pressure and provide feedback, helping individuals with diabetic nerve damage better sense their feet, thus preventing ulcers. Overall, evidence suggests these insoles effectively prevent foot ulcers in high-risk individuals.¹³⁵⁶⁷