Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
210 participants
INTERVENTIONAL
2021-10-19
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1: Reference Group
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.
Offloading Boot
Removable offloading boot in one of three configurations provided to participants
Group 2: Control Group
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.
Offloading Boot
Removable offloading boot in one of three configurations provided to participants
Group 3: SmartBoot
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.
Offloading Boot
Removable offloading boot in one of three configurations provided to participants
Interventions
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Offloading Boot
Removable offloading boot in one of three configurations provided to participants
Eligibility Criteria
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Inclusion Criteria
* ≥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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
University of Southern California
OTHER
Responsible Party
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David Armstrong
Professor
Principal Investigators
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David G Armstrong, DPN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor of Surgery, Keck School of Medicine of USC
Locations
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Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
Verdugo Hills Hospital of USC
Glendale, California, United States
Clemente Clinical Research
Los Angeles, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS-20-00526
Identifier Type: -
Identifier Source: org_study_id
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