Smart Boot Use to Measure Offloading Adherence

Last updated: January 14, 2026
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

2

Condition

Pressure Ulcer

Diabetes Mellitus Types I And Ii

Ulcers

Treatment

Offloading Boot

Boot

Clinical Study ID

NCT04460573
HS-20-00526
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • Wound present for > 1 year

  • HbA1c > 12%

  • ABI of index limb < 0.6 or non-detectable Doppler, and/or patient being consideredfor revascularization during the course of the study

  • Acute Charcot neuropathy or a major foot deformity that doesn't allow them to wearthe 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 thestudy

  • 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

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: Offloading Boot
Phase: 2
Study Start date:
October 19, 2021
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California 90242
    United States

    Site Not Available

  • Verdugo Hills Hospital of USC

    Glendale, California 91208
    United States

    Site Not Available

  • Clemente Clinical Research

    Los Angeles, California 90033
    United States

    Site Not Available

  • Keck Medical Center of USC

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Rancho Los Amigos National Rehabilitation Center

    Downey 5343858, California 5332921 90242
    United States

    Active - Recruiting

  • Verdugo Hills Hospital of USC

    Glendale 5352423, California 5332921 91208
    United States

    Active - Recruiting

  • Clemente Clinical Research

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

  • Keck Medical Center of USC

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

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