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

Award Number: R01DK124789
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/01/2021
PERIOD OF PERFORMANCE END DATE: 12/31/2026

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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).


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90033	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	12/18/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $368,171 )
2025	2025	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90033	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	12/31/2024	NON-COMPETING CONTINUATION	$368,171
														Subtotal = $368,171

Issue Date FY: 2024 ( Subtotal = $392,903 )
2024	2024	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90089	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	4	5/8/2024	NON-COMPETING CONTINUATION	$24,557
2024	2024	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90089	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	4	1/18/2024	NON-COMPETING CONTINUATION	$368,346
2024	2023	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90089	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	1/17/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $392,903

Issue Date FY: 2023 ( Subtotal = $409,317 )
2023	2023	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST	LOS ANGELES	CA	90089	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	1/6/2023	NON-COMPETING CONTINUATION	$409,317
														Subtotal = $409,317

Issue Date FY: 2022 ( Subtotal = $409,212 )
2022	2022	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	12/3/2021	NON-COMPETING CONTINUATION	$368,290
2022	2022	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	4/12/2022	NON-COMPETING CONTINUATION	$40,922
														Subtotal = $409,212

Issue Date FY: 2021 ( Subtotal = $425,653 )
2021	2021	UNIVERSITY OF SOUTHERN CALIFORNIA	3720 S FLOWER ST FL 3	LOS ANGELES	CA	90007	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	12/25/2020	NEW	$425,653
														Subtotal = $425,653

Grand Total All Awards = $2,005,256

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

Award Number: R01DK124789

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/01/2021

PERIOD OF PERFORMANCE END DATE: 12/31/2026

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