Tele-FootX: Virtually Supervised Tele-Exercise Platform for Accelerating Plantar Wound Healing

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Abstract Foot ulceration is the most common and costly late complication of diabetes, with morbidity and mortality being worse than many cancers. It is estimated that up to one-third of people with diabetes will develop a diabetic foot ulcer (DFU) in their lifetime. Non-healing DFUs are a leading cause of hospitalization, amputation, disability, and death among people with diabetes. In the United States, one-third of all diabetes-related costs are spent on diabetic foot care, with two-thirds of the costs incurred in inpatient settings, constituting a substantial economic burden to society. Therefore, every means possible should be used to try to heal DFU and prevent amputation. In this regard, there is a significant body of evidence related to the clinical benefits of exercise for people with DFU, including improving blood flow and oxygen supply, muscle loss prevention, and joint mobility. Despite this evidence, exercise is not part of the standard care for wound healing, mainly as there is no solution for promoting and managing home-based exercise programs for people with DFU. In this Phase I SBIR project, we will design an interactive foot and ankle exercise program for people with DFU using wearable sensors called Tele-FootX™. Tele-FootX will enable both remotely and virtually supervised evidence-based foot and ankle exercises and allow clinicians to educate, monitor, and coach patients. The gaming features of the platform will promote adherence to the prescribed exercise programs, and, subsequently, wound healing. This approach is supported by our proof-of-concept study, where we demonstrated the benefit of interactive foot and ankle exercises to improve lower extremity perfusion and increase activity in the calf muscle. To achieve this goal, in Aim 1, we will design an interactive game-based exercise platform using foot- mounted sensors and make it suitable for people with DFU by including game-based exercises inspired by the Buerger-Allen exercise program. In Aim 2, we will demonstrate the acceptability, feasibility, safety, and proof of concept effectiveness of the Tele-FootX in improving lower extremity perfusion by recruiting 15 participants with DFU. We will examine the perceived benefit, ease of use, technology acceptance, usability, and technology anxiety from the point of view of the 15 participants with DFU recruited in Aim 2, as well as 10 health care professionals with expertise in DFU management. In Phase II, we will introduce new gaming features to improve engagement, as well as features for clinicians to educate, manage and personalize the home-based exercise program for each patient. We will also integrate the proposed solution into existing hospital records and remote assessments (e.g., EPIC). We will validate the final product in a 12-week randomized control trial. There are existing CPT codes that cover tele-exercise programs. The existence of reimbursement codes (CPT codes 98975, 98977, 98980, and 98981), the large size of the market (26.1 million worldwide develop DUF annually), and the significant clinical benefits of the proposed solution will facilitate commercialization of Tele-FootX.