Diabetic Foot UlcerPhase 2NCT04460573
Smart Boot Use to Measure Offloading Adherence
A Phase 2 study testing Offloading Boot in people with Diabetic Foot Ulcer, run by University of Southern California at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Offloading Boot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Oct 2021to 31 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
Fabiola Rodriguez, MD, 3235162332, fabiola.rodriguez@med.usc.edu
- Recruiting
Verdugo Hills Hospital of USC
Glendale, California, 91208
Fabiola Rodriguez, 3235162332, fabiola.rodriguez@med.usc.edu
Bijan Najafi, PHD
- Recruiting
Clemente Clinical Research
Los Angeles, California, 90033
Scott Mathis, 3233304287, scott.mathis@clementeclinical.com
- Recruiting
Keck Medical Center of USC
Los Angeles, California, 90033
Fabiola A Rodriguez, MD, 3235162332, fabiola.rodriguez@med.usc.edu
About this study
Official title: Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading
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
- Being tested
- Offloading Boot
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offloading BootDevice
Removable offloading boot in one of three configurations provided to participants
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Reference Group | Active comparator | 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. Receives: Device: Offloading Boot |
| Group 2: Control Group | Active comparator | 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. Receives: Device: Offloading Boot |
| Group 3: SmartBoot | Experimental | 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. Receives: Device: Offloading Boot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing at 12 weeks or sooner
Wound healing is defined as complete epithelialization of the target ulcer, confirmed by standardized wound assessment. Healing status is recorded as a binary outcome (yes/no) for each participant. The proportion of participants achieving wound healing by 12 weeks is compared between randomized treatment arms.
Unit of Measure: %
Measured: Up to 12 weeks
Time to wound healing
Time to wound healing is defined as the number of days from randomization to confirm complete epithelialization of the target ulcer, as determined by standardized wound assessment.
Unit of Measure: Days
Measured: Up to 12 weeks
Secondary outcomes (4)
Patient acceptability
To evaluate participant acceptance of SmartBoot, the Technology Acceptance Model (TAM) questionnaire is administered. TAM is an intention-based framework widely used to assess user satisfaction and acceptance of new technologies. The questionnaire has 18 items: 9 assess perceived ease of use, 5 evaluate perceived benefits, 2 measure attitudes toward use, and 2 measure behavioral intention. Responses were rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The average scores across all categories are normalized from 0 to 100; higher values indicate better acceptability. A score of 75 or higher is considered indicative of an acceptable level of program acceptance.
Unit of Measure: unit on scale
Measured: Week 12
Participant dropout rate
Participant dropout is defined as discontinuation from the study before completion of the Week 12 visit. The dropout rate is calculated as the percentage of randomized participants who withdrew before Week 12.
Unit of Measure: %
Measured: From baseline through Week 12
Adherence to offloading
The average weekly adherence to offloading is assessed using a SmartBoot adherence algorithm based on device-on time during weight-bearing activity or the patient's self-reports. The algorithm reports a normalized adherence score ranging from 1 to 10, with lower scores indicating better adherence to prescribed offloading and higher scores indicating poorer adherence.
Unit of Measure: Unitless (normalized score, 1-10)
Measured: From baseline through Week 12 (summarized weekly)
Percentage of Wound Area Reduction
The percentage of wound area reduction healing will be defined as the percentage reduction in wound area relative to baseline and estimated over time using a longitudinal linear model. Wound area will be derived from standardized wound imaging acquired weekly. When weekly wound area measurements are missing, values will be estimated using linear interpolation. Absolute wound area values (cm²) will also be retained in the database for descriptive purposes.
- Unit of Measure: Percent reduction in wound area per week
Measured: Percent reduction in wound area per week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start19 Oct 2021
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, comparative randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, David Armstrong, University of Southern California
- Investigators
- David G Armstrong, DPN, MD, PhD, Principal investigator, Professor of Surgery, Keck School of Medicine of USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460573
- Sponsor's protocol ID
- HS-20-00526
- Status last verified
- Jan 2026
- First submitted
- 1 Jul 2020
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individually identifiable data will be deleted or masked before being made available to individuals who are not a part of the study (research staff). Results released will be sufficiently aggregated as to make individual identification of subjects highly unlikely. When individual research subjects are identifiable using substitute unique identifiers (i.e., subject 10) the translation table will be safeguarded from release outside of the study staff.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Science of Adherence Reinforcement and Safe Mobility in People With Diabetic Foot Ulcers Using Smart Offloading
- ClinicalTrials.gov ID
- NCT04460573
- Acronym / sponsor ID
- HS-20-00526
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- prospective, comparative randomized trial
| Arm | Type | Receives |
|---|---|---|
| Group 1: Reference Group | Active comparator | Device: Offloading BootThe 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. |
| Group 2: Control Group | Active comparator | Device: Offloading BootThe 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. |
| Group 3: SmartBoot | Experimental | Device: Offloading BootThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Offloading BootRemovable offloading boot in one of three configurations provided to participants | Device | Group 1: Reference Group, Group 2: Control Group, Group 3: SmartBoot |
Primary outcome
Wound healing at 12 weeks or sooner
Time frame: Up to 12 weeks
Wound healing is defined as complete epithelialization of the target ulcer, confirmed by standardized wound assessment. Healing status is recorded as a binary outcome (yes/no) for each participant. The proportion of participants achieving wound healing by 12 weeks is compared between randomized treatment arms. Unit of Measure: %
Time to wound healing
Time frame: Up to 12 weeks
Time to wound healing is defined as the number of days from randomization to confirm complete epithelialization of the target ulcer, as determined by standardized wound assessment. Unit of Measure: Days
4 secondary outcomes
Patient acceptability
Time frame: Week 12
Participant dropout rate
Time frame: From baseline through Week 12
Adherence to offloading
Time frame: From baseline through Week 12 (summarized weekly)
Percentage of Wound Area Reduction
Time frame: Percent reduction in wound area per week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. Individually identifiable data will be deleted or masked before being made available to individuals who are not a part of the study (research staff). Results released will be sufficiently aggregated as to make individual identification of subjects highly unlikely. When individual research subjects are identifiable using substitute unique identifiers (i.e., subject 10) the translation table will be safeguarded from release outside of the study staff.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David G Armstrong, DPN, MD, PhD principal investigator
Professor of Surgery, Keck School of Medicine of USC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Offloading Boot in people with Diabetic Foot Ulcer, run by University of Southern California at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabiola Rodriguez, MD (3235162332, fabiola.rodriguez@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing at 12 weeks or sooner (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.