Smart Boot Use to Measure Offloading Adherence

Last updated: October 4, 2024
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Ulcers

Treatment

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 wear a boot that can't be taken off. The second group will wear a boot that can be taken off, and they will get counseling about how important it is to follow instructions as to how often and when to wear the boot. The third group will wear a "smart" boot, which will interact with the person through a smart watch and smart phone, and give them direct feedback about how they are doing with following their boot wearing prescription.

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 aged 18 or older

  • Diabetic Foot Ulcer requiring offloading

  • Able to provide written informed consent

Exclusion

Exclusion Criteria:

  • Wound present for more than one year

  • HbA1c > 12%

  • Ankle Brachial Index (ABI) of index limb is <0.9 and/or they are being consideredfor revascularization within the course of the study

  • Ulcer involving bone or tendon

  • Ulcer not caused by diabetes

  • Unable or unwilling to attend prescribed clinic visits

  • Fully confined to a wheelchair

Study Design

Total Participants: 210
Treatment Group(s): 1
Primary Treatment: Boot
Phase: 2
Study Start date:
October 19, 2021
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California 90242
    United States

    Active - Recruiting

  • Verdugo Hills Hospital of USC

    Glendale, California 91208
    United States

    Active - Recruiting

  • Clemente Clinical Research

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Keck Medical Center of USC

    Los Angeles, California 90033
    United States

    Active - Recruiting

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