Improving the science of adherence reinforcement and safe mobility in people with diabetic foot ulcers using smart offloading

PROJECT SUMMARY/ABSTRACT
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).

Grant Number: 5R01DK124789-05
NIH Institute/Center: NIH
Principal Investigator: David Armstrong