Smart Boot Use to Measure Offloading Adherence
Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading
1 other identifier
interventional
210
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2021
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
October 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedJanuary 16, 2026
January 1, 2026
4.4 years
July 1, 2020
January 14, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Wound healing at 12 weeks or sooner
Wound healing is defined as complete epithelialization of the target ulcer, confirmed by standardized wound assessment. Healing status is recorded as a binary outcome (yes/no) for each participant. The proportion of participants achieving wound healing by 12 weeks is compared between randomized treatment arms. Unit of Measure: %
Up to 12 weeks
Time to wound healing
Time to wound healing is defined as the number of days from randomization to confirm complete epithelialization of the target ulcer, as determined by standardized wound assessment. Unit of Measure: Days
Up to 12 weeks
Secondary Outcomes (4)
Patient acceptability
Week 12
Participant dropout rate
From baseline through Week 12
Adherence to offloading
From baseline through Week 12 (summarized weekly)
Percentage of Wound Area Reduction
Percent reduction in wound area per week
Other Outcomes (9)
Change in gait speed
Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first
Change in body sway area
Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first
Sleep Quality
Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first
- +6 more other outcomes
Study Arms (3)
Group 1: Reference Group
ACTIVE COMPARATORThe 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.
Group 2: Control Group
ACTIVE COMPARATORThe 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.
Group 3: SmartBoot
EXPERIMENTALThe 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.
Interventions
Removable offloading boot in one of three configurations provided to participants
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
Verdugo Hills Hospital of USC
Glendale, California, 91208, United States
Clemente Clinical Research
Los Angeles, California, 90033, United States
Keck Medical Center of USC
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David G Armstrong, DPN, MD, PhD
Professor of Surgery, Keck School of Medicine of USC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 1, 2020
First Posted
July 7, 2020
Study Start
October 19, 2021
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
January 16, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
Individually identifiable data will be deleted or masked before being made available to individuals who are not a part of the study (research staff). Results released will be sufficiently aggregated as to make individual identification of subjects highly unlikely. When individual research subjects are identifiable using substitute unique identifiers (i.e., subject 10) the translation table will be safeguarded from release outside of the study staff.