Smart Boot Use to Measure Offloading Adherence

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04460573
• Other study ID #: HS-20-00526
• Status: Recruiting
• Phase: Phase 2
• Start date: October 19, 2021
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: University of Southern California
• Contact: Jason Garcia, BA
• Phone: 323-680-0196
• Email: Jason.garcia[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Device:
• Boot
Smart boot in one of three configurations provided to participants

Locations

Country	Name	City	State
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	Verdugo Hills Hospital of USC	Glendale	California
United States	Clemente Clinical Research	Los Angeles	California
United States	Keck Medical Center of USC	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	Percent healed	12 weeks
Primary	Adherence to offloading	Average daily hours of device wear during weight bearing activities, objectively measured using smart boot	12 weeks
Secondary	Speed of wound healing	Measured as average weekly change in area of wound	12 weeks
Secondary	Physical Activity	Measured by smart boot	12 weeks