What this study is
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.
What's being tested
- Offloading Boot
Intervention · DEVICE
Removable offloading boot in one of three configurations provided to participants
Study details
- Official title
- Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading
- Sponsor
- University of Southern California
- Conditions
- Diabetic Foot Ulcer
- Enrolling
- 210 people
- Starts
- 2021-10-19
- Est. completion
- 2026-03-31
- Design
- Single-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openRancho Los Amigos National Rehabilitation Center
Downey, California, United States
- Fabiola Rodriguez, MD · Contact3235162332fabiola.rodriguez@med.usc.edu
RecruitingVerdugo Hills Hospital of USC
Glendale, California, United States
- Fabiola Rodriguez · Contact3235162332fabiola.rodriguez@med.usc.edu
- Bijan Najafi, PHD · Principal investigator
RecruitingClemente Clinical Research
Los Angeles, California, United States
- Scott Mathis · Contact3233304287scott.mathis@clementeclinical.com
RecruitingKeck Medical Center of USC
Los Angeles, California, United States
- Fabiola A Rodriguez, MD · Contact3235162332fabiola.rodriguez@med.usc.edu
Recruiting
Study team
Sponsor
University of Southern California
Study ID HS-20-00526
Principal investigator
David G Armstrong, DPN, MD, PhD
Professor of Surgery, Keck School of Medicine of USC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.