Using smart boots to improve adherence in diabetic foot ulcer treatment
Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading
This study is testing whether different types of diabetic boots can help people with foot ulcers stick to their treatment and heal better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 4 sites (Downey, California and 3 other locations) |
| Trial ID | NCT04460573 on ClinicalTrials.gov |
What this trial studies
This study aims to assist individuals with diabetic foot ulcers by evaluating the effectiveness of three different types of diabetic boots in promoting adherence to treatment. Participants will be divided into three groups: one will wear a non-removable boot, another will wear a removable boot with counseling on adherence, and the third will use a 'smart' boot that provides real-time feedback through a smartwatch and smartphone. The goal is to determine which boot type encourages better compliance with wearing the boot as prescribed, ultimately aiding in the healing process of foot ulcers.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 or older with diabetic foot ulcers requiring offloading.
Not a fit: Patients with wounds present for more than one year or those with ulcers not caused by diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of amputation for patients with diabetic foot ulcers by improving adherence to offloading treatment.
How similar studies have performed: While there have been studies on diabetic foot ulcer treatments, the use of smart technology for adherence monitoring in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Downey, California and 3 other locations
- Rancho Los Amigos National Rehabilitation Center — Downey, California, United States (Recruiting)
- Verdugo Hills Hospital of USC — Glendale, California, United States (Recruiting)
- Clemente Clinical Research — Los Angeles, California, United States (Recruiting)
- Keck Medical Center of USC — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: David G Armstrong, DPN, MD, PhD — Professor of Surgery, Keck School of Medicine of USC
- Study coordinator: Fabiola Rodriguez, MD
- Email: fabiola.rodriguez@med.usc.edu
- Phone: 3235162332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.