Smart Boot Use to Measure Offloading Adherence

Phase 2RecruitingNCT04460573

University of Southern California210 enrolled

Overview

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 use removable offloading with reinforced education emphasizing continuous wear, including during rest and sleep, and not to remove it at any time. The second group will use removable offloading consistent with standard of care and receive education on recommended wear during walking or standing, with permission to remove the device during rest and sleep. The third group will use a smart removable offloading device that provides real-time adherence feedback via a smartwatch and smartphone, with additional personalized education informed by remotely monitored adherence data. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

210

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female * ≥18 years old * Non-infected, non-ischemic DFU requiring offloading * Ambulatory at home with or without assistance * Willing and able to provide written informed consent Exclusion Criteria: * Wound present for \> 1 year * HbA1c \> 12% * ABI of index limb \< 0.6 or non-detectable Doppler, and/or patient being considered for revascularization during the course of the study * Acute Charcot neuropathy or a major foot deformity that doesn't allow them to wear the smart boot * Amputation proximal to the rearfoot on the affected extremity * Any clinically significant medical or psychiatric condition * Laboratory abnormality that would interfere with the ability to participate in the study * Concurrently participating in exercise training * Changes in psychotropic or sleep medication in the last 6 weeks * Ulcer involves bone * Ulcer not of diabetic origin * Unable or unwilling to attend prescribed clinic visits or comply with protocol

Outcomes

Primary Outcomes

Wound healing at 12 weeks or sooner

Wound healing is defined as complete epithelialization of the target ulcer, confirmed by standardized wound assessment. Healing status is recorded as a binary outcome (yes/no) for each participant. The proportion of participants achieving wound healing by 12 weeks is compared between randomized treatment arms. Unit of Measure: %

Time frame: Up to 12 weeks

Time to wound healing

Time to wound healing is defined as the number of days from randomization to confirm complete epithelialization of the target ulcer, as determined by standardized wound assessment. Unit of Measure: Days

Time frame: Up to 12 weeks

Secondary Outcomes

Patient acceptability

To evaluate participant acceptance of SmartBoot, the Technology Acceptance Model (TAM) questionnaire is administered. TAM is an intention-based framework widely used to assess user satisfaction and acceptance of new technologies. The questionnaire has 18 items: 9 assess perceived ease of use, 5 evaluate perceived benefits, 2 measure attitudes toward use, and 2 measure behavioral intention. Responses were rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The average scores across all categories are normalized from 0 to 100; higher values indicate better acceptability. A score of 75 or higher is considered indicative of an acceptable level of program acceptance. Unit of Measure: unit on scale

Time frame: Week 12

Participant dropout rate

Participant dropout is defined as discontinuation from the study before completion of the Week 12 visit. The dropout rate is calculated as the percentage of randomized participants who withdrew before Week 12. Unit of Measure: %

Time frame: From baseline through Week 12

Adherence to offloading

The average weekly adherence to offloading is assessed using a SmartBoot adherence algorithm based on device-on time during weight-bearing activity or the patient's self-reports. The algorithm reports a normalized adherence score ranging from 1 to 10, with lower scores indicating better adherence to prescribed offloading and higher scores indicating poorer adherence. Unit of Measure: Unitless (normalized score, 1-10)

Time frame: From baseline through Week 12 (summarized weekly)

Percentage of Wound Area Reduction

The percentage of wound area reduction healing will be defined as the percentage reduction in wound area relative to baseline and estimated over time using a longitudinal linear model. Wound area will be derived from standardized wound imaging acquired weekly. When weekly wound area measurements are missing, values will be estimated using linear interpolation. Absolute wound area values (cm²) will also be retained in the database for descriptive purposes. \- Unit of Measure: Percent reduction in wound area per week

Time frame: Percent reduction in wound area per week