Smart Boot Use to Measure Offloading Adherence

University of Southern California

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Foot Ulcer

Treatments: Device: Boot

Study type: Interventional

Funder types: Other

Identifiers

NCT04460573

HS-20-00526

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 3 patient groups

Smart boot irremovable

Active Comparator group

Description:

Smart boot rendered irremovable with cohesive bandage; no feedback on adherence.

Treatment:

Device: Boot

Smart boot removable

Active Comparator group

Description:

Smart boot, removable, without feedback on adherence.

Treatment:

Device: Boot

Smart boot removable+reinforcement

Experimental group

Description:

Smart boot with, removable, with reinforcement of adherence via smart watch and smart phone as well as remote patient monitoring.

Treatment:

Device: Boot