Smart Boot Use to Measure Offloading Adherence

Conditions

• Diabetic Foot Ulcer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Offloading Boot — DEVICE
  Removable offloading boot in one of three configurations provided to participants

Study Details

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 Dates

Start date

Oct 19, 2021

Status verified

Jan 2026

Primary completion

Mar 31, 2026

Completion

Mar 31, 2026

Study Design

Enrollment

210 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 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.
• Active Comparator: 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.
• Experimental: 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.

Primary Outcome Measure

Wound healing at 12 weeks or sooner [ Time Frame: Up to 12 weeks ]

Central Contacts

• Fabiola Rodriguez, MD
  3235162332
  [email protected]
• Bijan Najafi, PHD
  5244677127
  [email protected]

Locations (4)

Find similar trials in Downey, CA

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