RECRUITING

Smart Boot Use to Measure Offloading Adherence

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading

Quick Facts

Study Start:2021-10-19
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04460573

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female
  2. * ≥18 years old
  3. * Non-infected, non-ischemic DFU requiring offloading
  4. * Ambulatory at home with or without assistance
  5. * Willing and able to provide written informed consent
  1. * Wound present for \> 1 year
  2. * HbA1c \> 12%
  3. * ABI of index limb \< 0.6 or non-detectable Doppler, and/or patient being considered for revascularization during the course of the study
  4. * Acute Charcot neuropathy or a major foot deformity that doesn't allow them to wear the smart boot
  5. * Amputation proximal to the rearfoot on the affected extremity
  6. * Any clinically significant medical or psychiatric condition
  7. * Laboratory abnormality that would interfere with the ability to participate in the study
  8. * Concurrently participating in exercise training
  9. * Changes in psychotropic or sleep medication in the last 6 weeks
  10. * Ulcer involves bone
  11. * Ulcer not of diabetic origin
  12. * Unable or unwilling to attend prescribed clinic visits or comply with protocol

Contacts and Locations

Study Contact

Fabiola Rodriguez, MD
CONTACT
3235162332
fabiola.rodriguez@med.usc.edu
Bijan Najafi, PHD
CONTACT
5244677127
bnajafi@mednet.ucla.edu

Principal Investigator

David G Armstrong, DPN, MD, PhD
PRINCIPAL_INVESTIGATOR
Professor of Surgery, Keck School of Medicine of USC

Study Locations (Sites)

Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
United States
Verdugo Hills Hospital of USC
Glendale, California, 91208
United States
Clemente Clinical Research
Los Angeles, California, 90033
United States
Keck Medical Center of USC
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • David G Armstrong, DPN, MD, PhD, PRINCIPAL_INVESTIGATOR, Professor of Surgery, Keck School of Medicine of USC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-19
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2021-10-19
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Foot Ulcer