Smart Boot Use to Measure Offloading Adherence
Key facts
- Who runs it
- University of Southern California
- Where
- Downey, Glendale, and Los Angeles, United StatesSee the 4 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 210 people, planned
- Started
- 19 Oct 2021
- Planned end
- 31 Mar 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Offloading Boot
- Record updated
- 16 January 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Changes in psychotropic or sleep medication in the last 6 weeks
- Any clinically significant medical or psychiatric condition
- Ulcer involves bone
- Ulcer not of diabetic origin
- HbA1c > 12%
- Laboratory abnormality that would interfere with the ability to participate in the study
- Wound present for > 1 year
- 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
- Concurrently participating in exercise training
- Unable or unwilling to attend prescribed clinic visits or comply with protocol
Where in United States
- Rancho Los Amigos National Rehabilitation CenterDowney, United StatesContact: Fabiola Rodriguez, MDTaking people
- Verdugo Hills Hospital of USCGlendale, United StatesContact: Fabiola RodriguezTaking people
- Clemente Clinical ResearchLos Angeles, United StatesContact: Scott MathisTaking people
- Keck Medical Center of USCLos Angeles, United StatesContact: Fabiola A Rodriguez, MDTaking people
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- Group 1: Reference GroupExisting treatment, for comparison
The group 1 will receive above-standard of care intervention, which includes wearing a standard removable boot and enhanced eductaion with weekly adherence reinforcement. In this group, participants are interviewed weekly, adherence is reviewed, and education is reinforced at each visit. Participants are instructed to wear the offloading device at all times, including during rest and at night, and not to remove it at any time.
Treatment: Offloading Boot
- Group 2: Control GroupExisting treatment, for comparison
The control group uses removable offloading and represents the standard of care. These participants receive education at baseline and are advised to wear the offloading device during walking or standing; however, they are allowed to remove it during rest and sleep.
Treatment: Offloading Boot
- Group 3: SmartBootTreatment being tested
The SmartBoot group follows a similar protocol to the control group, but adherence to wearing offloading during weight-bearing activities is reinforced using a smartwatch. The smartwatch provides real-time reminders when participants walk without the offloading device. In addition, data from remote patient monitoring may help personalize education during weekly clinic visits conducted by the research coordinator.
Treatment: Offloading Boot
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading
- Record updated
- 16 January 2026