Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading

  • STATUS
    Recruiting
  • End date
    Dec 23, 2025
  • participants needed
    250
  • sponsor
    University of Southern California
Updated on 23 October 2022
diabetes
foot ulcer

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.

Details
Condition Diabetic Foot Ulcer
Treatment BOOT
Clinical Study IdentifierNCT04460573
SponsorUniversity of Southern California
Last Modified on23 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or Female aged 18 or older
Diabetic Foot Ulcer requiring offloading
Able to provide written informed consent

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 considered for 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
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