Diabetic Foot Ulcer
Conditions
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 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.
Interventions
DEVICEOffloading Boot
Removable offloading boot in one of three configurations provided to participants
Sponsors
University of California, Los Angeles
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
prospective, comparative randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing at 12 weeks or sooner | Up to 12 weeks | 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 to wound healing | Up to 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient acceptability | Week 12 | 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 |
| Participant dropout rate | From baseline through Week 12 | 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: % |
| Adherence to offloading | From baseline through Week 12 (summarized weekly) | 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) |
| Percentage of Wound Area Reduction | Percent reduction in wound area per week | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first | Depressive symptoms were assessed using the Center for Epidemiologic Studies Depression Scale (CES-D), which yields scores ranging from 0 to 60, with higher scores indicating greater symptom burden. Scores of 16 or higher will be used to indicate elevated depressive symptoms and are reported for descriptive purposes. Unit of Measure: Unit on scale (0-60) |
| Change in gait speed | Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first | Gait speed (m/s) is assessed using validated wearable sensor-based measurements. Change in gait speed from baseline is calculated as the average change from baseline at each monthly follow-up assessment. A higher reduction indicates slower gait and potentially a sign of lower extremity muscle atrophy in response to offloading treatment. \- Unit of Measure: m/s |
| Fall Efficacy Score | Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first | Fear of falling is assessed using the Falls Efficacy Scale-International (FES-I), which yields scores ranging from 16 to 64, with higher scores indicating greater concern about falling. Scores of 28 or higher will be used to reflect a high concern about falling and are reported descriptively. Unit of Measure: Unit on scale (16-64) |
| Mobility Assessment | Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first | Mobility is assessed using the Life-Space Questionnaire, which yields scores ranging from 0 to 120, with higher scores indicating greater mobility. Lower scores reflect more restricted life-space mobility and are reported descriptively. Scores of 60 or lower are considered restricted life-space mobility. Unit of Measure: Unit on scale (0-120) |
| Change in body sway area | Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first | * Outcome Measure Description: Postural control is assessed using validated wearable sensor-based measurements of body sway area (cm2) during quiet standing in a double-stance, eyes-open condition. Change in body sway area is calculated as the average change from baseline at each monthly follow-up assessment. A higher value can potentially be a sign of lower extremity muscle atrophy in response to offloading treatment. * Unit of Measure: cm\^2 |
| Sleep Quality | Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first | Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI), which yields a global score ranging from 0 to 21, with higher scores indicating worse sleep quality. Scores greater than 5 have been used to indicate poor sleep quality and are reported here for descriptive interpretation. Unit of Measure: Unit on scale (0-21) |
| Overall Health | Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first | Overall health is assessed using the PROMIS-29 Profile, which measures seven health domains (Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles/Activities, and Pain Interference). Results are reported as T-scores standardized to the U.S. general population (mean = 50, SD = 10). For Physical Function and Social Roles, higher scores indicate better health; for all other domains, higher scores indicate greater symptom burden. Scores of 60 or higher on symptom scales or 40 or lower on function scales reflect moderate-to-severe impairment and are reported descriptively. Unit of Measure: T-score for each of 7 domains |
| Frailty (Trauma-Specific Frailty Index) | Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first | Frailty is assessed using the Trauma-Specific Frailty Index, calculated as the proportion of accumulated health deficits, with scores ranging from 0 to 1. Higher values indicate greater frailty. A value of approximately 0.25 will be used as a reference threshold for frailty and is reported descriptively. Unit of Measure: Unit on scale (0-1) |
| Frailty (Fried Frailty Criteria) | Baseline and monthly up to 12 weeks or until complete wound healing, whichever occurs first | Frailty status is assessed using the Fried Frailty Criteria, which classify individuals based on five components. Scores range from 0 to 5, with higher scores indicating greater frailty. Categories of robust (0), pre-frail (1-2), and frail (≥3) are reported descriptively. Unit of Measure: Unit on scale (0-5) |
Countries
United States
Contacts
Primary ContactFabiola Rodriguez, MD
Backup ContactBijan Najafi, PHD
Outcome results
None listed