Smart Boot Use to Measure Offloading Adherence

Phase 2

Recruiting

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: Boot

• Registration Number: NCT04460573
• Lead Sponsor: University of Southern California

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Study Start: 2021-10-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smart boot removable+reinforcement	Boot	Smart boot with, removable, with reinforcement of adherence via smart watch and smart phone as well as remote patient monitoring.
Smart boot removable	Boot	Smart boot, removable, without feedback on adherence.
Smart boot irremovable	Boot	Smart boot rendered irremovable with cohesive bandage; no feedback on adherence.

Primary Outcome Measures

Name	Time	Method
Adherence to offloading	12 weeks	Average daily hours of device wear during weight bearing activities, objectively measured using smart boot
Wound healing	12 weeks	Percent healed

Secondary Outcome Measures

Name	Time	Method
Speed of wound healing	12 weeks	Measured as average weekly change in area of wound
Physical Activity	12 weeks	Measured by smart boot

Trial Locations

Locations (4)

Keck Medical Center of USC; 🇺🇸 Los Angeles, California, United States

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States

Clemente Clinical Research; 🇺🇸 Los Angeles, California, United States

Verdugo Hills Hospital of USC; 🇺🇸 Glendale, California, United States