Method, Device and System for Appendage Protection Therapy (Smart Offloading Boot)

Background: Diabetic foot ulcers impact nearly 1 in 4 patients with diabetes. Over 50% of those who do develop foot ulcers requiring hospitalization at some point in their lives. Once infection sets in, amputation may be the only option for the patient's survival. Approximately 1 in 5 foot ulcers will require amputation, and over 80% of lower limb, non-traumatic amputations occur in patients with diabetes. Every year more than 82,000 amputations are performed on diabetics in the United States alone. Worldwide someone loses a limb to diabetes every 20 seconds. For diabetic patients the 5 year mortality rate after a limb amputation is 68%, second only to lung cancer. These staggering numbers necessitate the creation of ways to reduce, heal and prevent foot wounds, both in diabetic patients and in the general population. There is a clear need for a device that has the capacity to minimize weight bearing, monitor conditions that may impact healing, and allow for clinicians to have access to the wound.

Invention: This technology provides an orthopedic device that can measure different factors that could affect wound healing, such as physical stress and pressure, foot positioning, pH, blood flow, and skin temperature. All of these factors may assist in the stabilization and proper healing of ulcerative and/or post-operative conditions of the foot, especially for patients suffering from diabetic foot ulcers. 

Applications: This orthotic device seeks to maximize healing of ulcerative foot conditions and other wounds of the food. The device seeks to minimize weight bearing on certain areas of the foot as well as allow medical providers the ability to view the condition of the foot. This technology may improve a patient’s ability  to live an active lifestyle while allowing for proper healing for foot ulcerations and other foot wounds.

Advantages: One advantage of the current invention is that the proposed technology allows providers to adjust a patient’s treatment regime in response to clinical factors to improve wound healing. In addition, the boot features a window of observation for medical providers to monitor wound healing, and determine if medical removal of dead, damaged, or infected tissue is needed to improve the healing of the remaining healthy tissue.