Smart Boot Use to Measure Offloading Adherence

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Boot


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, comparative randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Smart boot irremovable<br>Smart boot rendered irremovable with cohesive bandage; no feedback on adherence. | Device: Boot<br>* Smart boot in one of three configurations provided to participants<br>|
| Active Comparator: Smart boot removable<br>Smart boot, removable, without feedback on adherence. | Device: Boot<br>* Smart boot in one of three configurations provided to participants<br>|
| Experimental: Smart boot removable+reinforcement<br>Smart boot with, removable, with reinforcement of adherence via smart watch and smart phone as well as remote patient monitoring. | Device: Boot<br>* Smart boot in one of three configurations provided to participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Percent healed | 12 weeks | 
| Adherence to offloading | Average daily hours of device wear during weight bearing activities, objectively measured using smart boot | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of wound healing | Measured as average weekly change in area of wound | 12 weeks | 
| Physical Activity | Measured by smart boot | 12 weeks |