We aim to reduce the limb-threatening and life-limiting burden of neuropathic diabetic foot ulcers (DFU) by advancing science in its most critical component: protective pressure offloading. We intend to do this via a randomized comparative effectiveness study of a first-ever smart removable offloading device (MOTUS Smart), which enables objective monitoring of adherence as well as adherence reinforcement (real-time notification of poor adherence via smartwatch + feedback via smartphone). Prescribed offloading, such as a removable cast walker (RCW), is used to reduce pressure on the bottom of the foot to protect the DFU. This allows it to heal while allowing the patient to be mobile. These devices can be a key component of healing and prevention of DFU. Unfortunately, patient adherence with these devices is poor. While irremovable offloading devices could address this challenge, they have other limitations including poor acceptability (because of its irremovability during sleep and shower), poor scalability (e.g., only 2% of U.S. clinics regularly prescribe this gold-standard therapy), poor patient-centered outcomes (e.g., poor sleep quality), and high likelihood of deconditioning (frailty/leg muscle atrophy) induced by offloading because of prolonged ankle joint immobilization leading to high recurrence rate of DFU. Another scientific gap in the field is poor understanding of the influence of weight-bearing activity on plantar wound healing. Some report that regular weight-bearing activity even while wearing protected offloading may delay healing. Others suggest that stable and appropriately dosed protected weight-bearing exercise is beneficial to accelerate healing. Given the debilitating nature of DFU and the high cost of treatment, there is a need for novel technological approaches to motivate neuropathic patients without normal painful feedback to adhere to prescribed offloading and to enable clinicians to monitor and counsel patients on physical activity and adherence. In this study, we will enroll 216 ambulatory patients with active DFU randomized to three groups (ratio: n=1:1:1). The first group includes the gold-standard treatment, an irremovable boot (which forces patients into adhering to protective offloading of pressure). The second group includes an otherwise identically equipped traditional removable device along with traditional counseling regarding the importance of adherence to offloading. The third group will include a ?smart? removable cast walker that includes adherence reinforcement and remote patient monitoring. All three groups? devices will be embedded with sensors that will allow monitoring of adherence and activity. This study enables us to examine the benefit of adherence reinforcement to speed up wound healing (Aim 1); the association between dosage of physical activity and wound healing (Aim 2); and patient-centered outcomes between the three treatment arms (Aim 3).
People with diabetes often develop neuropathic diabetic foot ulcers (DFU) which are costly to treat, impair mobility and general well-being, and often turn into chronic wounds that can eventually result in amputation and increased mortality. This study aims to reduce the burden of limb-threatening and life-limiting DFU via advancing the science in offloading adherence and smart management of the magnitude of physical activity (PA) in people with active DFU. This will be done using an innovative and interactive protective offloading device, mobile health, and positive adherence reinforcement in the context of a hypothesis driven clinical trial.
