Wearable Insoles for Recurrent Diabetic Ulcer Prevention (WIREDUP)

Johns Hopkins University, Baltimore MD

Investigators

Abstract

PROJECT SUMMARY Diabetic foot ulcers (DFU) affect over 4 million adults with diabetes in the US. Adults with diabetes have a 30% likelihood of developing a DFU during their lifetime and DFUs are associated with substantial morbidity and mortality. More than 80% of all lower extremity amputations are the result of a DFU. The majority of DFUs have a neuropathic etiology and appear on the plantar surface of the foot as the result of decreased sensation and repetitive trauma. Prompt prevention and treatment of DFU is critical to decreasing amputation rates and improving limb outcomes in patients with diabetes. Even after healing is achieved, DFU recurrence is common. Up to 50% of adults with a history of DFU will develop a recurrent ulcer within one year of healing, and approximately 70% of affected adults will develop a recurrent DFU within 5 years. The standard clinical approach to DFU prevention includes regular foot examinations and offloading therapy, where patients with healed DFU are given special shoes or insoles to redistribute plantar pressure points away from a previously affected area of the foot. Even in a setting with proactive surveillance and offloading programs, one-year ulcer recurrence is typically greater than 30%. Interactive sensory insoles (Orpyx Medical Technologies Inc.) is a novel foot overload warning device designed to monitor gait parameters including plantar pressure, plantar temperature, and step count in adults with diabetes. Unlike standard offloading therapy, interactive sensory insoles provide real-time cues for pressure offloading to patients via a smartphone application, and transmit data to healthcare providers via a HIPAA-compliant dashboard for concurrent remote patient monitoring. We have completed a feasibility trial of interactive sensory insoles and demonstrated excellent usability and patient engagement. However, it is unclear if this technology can reduce the risk of DFU recurrence in adults with recently healed ulcers. We propose to assess the efficacy of using interactive sensory insoles for the prevention of recurrent DFU in a single-blinded randomized controlled trial. Primary Aim 1: Determine whether use of an interacgtive sensory insole with real-time patient feedback and remote patient monitoring can reduce plantar DFU recurrence compared to standard offloading alone among adults with a recently healed DFU. Secondary Aim 2: Assess patient-reported outcomes related to the use of interactive vs. non-interactive sensory insoles. Exploratory Aim 3: Assess DFU-related healthcare charges for patients randomized to using interactive vs. non-interactive sensory insoles. Impact: There is a critical need for better DFU prevention strategies, particularly for high-risk patients with prior DFU. Existing clinical paradigms with basic foot offloading and annual foot exams only minimally decrease the risk of recurrent DFU. Study results will provide actionable data about the efficacy of using patient-interactive sensory insole technology to monitor and prevent DFU formation in adults at high risk for diabetic foot complications, potentially changing the way DFU prevention is approached moving forward.