Using smart boots to improve adherence in diabetic foot ulcer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.