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

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.

Interventions

• Device Offloading Boot
  Removable offloading boot in one of three configurations provided to participants

Primary outcome measures

• Wound healing at 12 weeks or sooner [Time frame: Up to 12 weeks]
• Time to wound healing [Time frame: Up to 12 weeks]

Secondary outcome measures (4)

• Patient acceptability [Time frame: Week 12]
• Participant dropout rate [Time frame: From baseline through Week 12]
• Adherence to offloading [Time frame: From baseline through Week 12 (summarized weekly)]
• Percentage of Wound Area Reduction [Time frame: Percent reduction in wound area per week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 4 centers

• Rancho Los Amigos National Rehabilitation Center — Downey
• Verdugo Hills Hospital of USC — Glendale
• Clemente Clinical Research — Los Angeles
• Keck Medical Center of USC — Los Angeles

Identifiers

NCT: NCT04460573 · HS-20-00526

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗