Clinical trial NCT04460573: Smart Boot Use to Measure Offloading Adherence
Official title: Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2020-07-07
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, comparative randomized trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Wound healing
timeFrame: 12 weeks
measure: Adherence to offloading
timeFrame: 12 weeks
Secondary outcomes:
measure: Speed of wound healing
timeFrame: 12 weeks
measure: Physical Activity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Glendale
country: United States
facility: Verdugo Hills Hospital of USC
state: California
city: Los Angeles
country: United States
facility: Clemente Clinical Research
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
Study officials:
affiliation: Professor of Surgery, Keck School of Medicine of USC
name: David G Armstrong, DPN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: