Smart Boot Use to Measure Offloading Adherence

Recruiting now · Phase 2

Conditions studied: Diabetic Foot Ulcer

In brief

The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can increase the chance of amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed. The investigators will look at three groups of participants: the first group will use removable offloading with reinforced education emphasizing continuous wear, including during rest and sleep, and not to remove it at any time. The second group will use removable offloading consistent with standard of care and receive education on recommended wear during walking or standing, with permission to remove the device during rest and sleep. The third group will use a smart removable offloading device that provides real-time adherence feedback via a smartwatch and smartphone, with additional personalized education informed by remotely monitored adherence data. The investigators will also be looking at how much physical activity, like walking, the participants do. And they will compare how well participants sleep and rate their quality of life in the three different boots. The investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.

Key facts

Study ID

NCT04460573

Run by

University of Southern California

People needed

210

Starts

2021-10-19

Expected to finish

2026-03-31

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female
• ≥18 years old
• Non-infected, non-ischemic DFU requiring offloading
• Ambulatory at home with or without assistance
• Willing and able to provide written informed consent

You may not qualify if…

• Wound present for > 1 year
• HbA1c > 12%
• ABI of index limb < 0.6 or non-detectable Doppler, and/or patient being considered for revascularization during the course of the study
• Acute Charcot neuropathy or a major foot deformity that doesn't allow them to wear the smart boot
• Amputation proximal to the rearfoot on the affected extremity
• Any clinically significant medical or psychiatric condition
• Laboratory abnormality that would interfere with the ability to participate in the study
• Concurrently participating in exercise training
• Changes in psychotropic or sleep medication in the last 6 weeks
• Ulcer involves bone
• Ulcer not of diabetic origin
• Unable or unwilling to attend prescribed clinic visits or comply with protocol

Where it is running

• Rancho Los Amigos National Rehabilitation Center — Downey, California, United States (enrolling)
• Verdugo Hills Hospital of USC — Glendale, California, United States (enrolling)
• Clemente Clinical Research — Los Angeles, California, United States (enrolling)
• Keck Medical Center of USC — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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