Recruiting
Phase 2

Observational Study

Sponsor:

University of Southern California

Code:

NCT04460573

Conditions

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Offloading Boot

Study Details

Brief summary:

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.

Conditions

Diabetic Foot Ulcer

Study ID

NCT04460573

Start date

Oct 19, 2021

Status verified date

Jan, 2026

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group 1: Reference Group

The group 1 will receive above-standard of care intervention, which includes wearing a standard removable boot and enhanced eductaion with weekly adherence reinforcement. In this group, participants are interviewed weekly, adherence is reviewed, and education is reinforced at each visit. Participants are instructed to wear the offloading device at all times, including during rest and at night, and not to remove it at any time.

active comparator: Group 2: Control Group

The control group uses removable offloading and represents the standard of care. These participants receive education at baseline and are advised to wear the offloading device during walking or standing; however, they are allowed to remove it during rest and sleep.

experimental: Group 3: SmartBoot

The SmartBoot group follows a similar protocol to the control group, but adherence to wearing offloading during weight-bearing activities is reinforced using a smartwatch. The smartwatch provides real-time reminders when participants walk without the offloading device. In addition, data from remote patient monitoring may help personalize education during weekly clinic visits conducted by the research coordinator.

Interventions

Offloading Boot

Removable offloading boot in one of three configurations provided to participants

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Fabiola Rodriguez, MD

3235162332fabiola.rodriguez@med.usc.edu

Bijan Najafi, PHD

5244677127bnajafi@mednet.ucla.edu

Locations

Rancho Los Amigos National Rehabilitation Center

Recruiting

Downey, California, United States, 90242

Contacts

Fabiola Rodriguez, MD

3235162332fabiola.rodriguez@med.usc.edu

Verdugo Hills Hospital of USC

Recruiting

Glendale, California, United States, 91208

Contacts

Fabiola Rodriguez

3235162332fabiola.rodriguez@med.usc.edu

Principal Investigator:

Bijan Najafi, PHD

Clemente Clinical Research

Recruiting

Los Angeles, California, United States, 90033

Contacts

Scott Mathis

3233304287scott.mathis@clementeclinical.com

Keck Medical Center of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Fabiola A Rodriguez, MD

3235162332fabiola.rodriguez@med.usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-01-16.