Ankle SprainsNCT06868316
Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability
A study testing Walking, Rucking and Running in people with Ankle Sprains and Ankle Injuries and Disorders, run by Danielle Torp at 2 sites in United States.
Trial summary
The goal of this randomized clinical controlled trial is examine the effects of gait training with auditory biofeedback (AudFB) on gait biomechanics, clinical measures of ankle joint health, and patient-centered outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Sprains, Ankle Injuries and Disorders
- What is being tested?
- Walking, Rucking and Running
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 May 2025to Sep 2028
- Phase
- Interventional
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active adults (defined as participants reporting a score of =4 on the National Aeronautics and Space Administration (NASA) Activity Instrument and indicating they can run for at least 20 consecutive minutes)
- History of ankle sprain
- 2 episodes of "giving way" in the past 6-months
- must answer "yes" to =5 questions on the Ankle Instability Instrument (AII) and =11 on the Identification of Functional Ankle Instability (IdFAI)
Who cannot join
- an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months
- history of surgery in the lower extremity
- fracture to the lower extremity in the past 12 months or a fracture that required open-reduction internal fixation
- history of neurological disease, vestibular or visual disturbance or any other pathology that would impair sensorimotor performance or gait
- current participation in a formal ankle joint rehabilitation program
- a concussion in the last 12 months
- report a cardiovascular, metabolic, or renal disease, or signs and symptoms that suggest such condition or have been told by a medical provider not to engage in vigorous physical activity (such as running).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of North Carolina at Charlotte
Charlotte, North Carolina, 28223
Luke Donovan, PhD, ATC, 704-687-8611, ldonova2@charlotte.edu
Luke Donovan, PhD, ATC
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Danielle Torp, PhD, ATC
Kyle Kosik, PhD, ATC
About this study
Official title: Optimizing Retention on Duty in Patients With Chronic Ankle Instability Using Auditory Biofeedback Gait Training: A Multisite Randomized Controlled Trial
The goal of this randomized clinical controlled trial is examine the effects of gait training with auditory biofeedback (AudFB) on gait biomechanics, clinical measures of ankle joint health, and patient-centered outcomes. The following specific aims will achieve this objective:
- Specific Aim 1: Determine if a 6-week gait training with AudFB intervention improves lower extremity biomechanics compared to a Control condition in participants with CAI.
- Specific Aim 2: Determine if a 6-week gait training with AudFB reduces talar cartilage deformation compared to a Control condition in participants with CAI.
- Specific Aim 3: Determine if a 6-week gait training with AudFB reduces episodes of ankle giving-way and reduces self-perceived severity of symptoms relative to a Control condition in participants with CAI.
Read more
Participants will:
- Complete 12 intervention sessions over a 6-week period of walking, ruck marching, and runninig.
- Complete testing sessions before and after the intervention, then after 6 and 12-months following the intervention.
Read the detailed description
Background: Ankle injuries account for the highest musculoskeletal injuries among conventional and special warfare combatants. In the civilian population, 40% of lateral ankle sprain patients will develop chronic ankle instability (CAI). If the same frequency is true in military settings, then up to 36,800 service members develop CAI annually. CAI contributes to the total number of medically non-available service members, creates a substantial economic burden, impacts the quality of duty-relevant task performance, and generates a large population of service members who require long-term care after retirement. There are no evidence-based gait training interventions for patients with CAI despite abnormal biomechanical patterns leading to recurring injuries linked to ankle osteoarthritis (OA) development. Overall, the current rehabilitation strategies are insufficient for preventing complications following an ankle sprain.
Hypothesis/Objectives: The overall objective of this study is to examine the effects of gait training with auditory feedback (AudFB) on gait biomechanics, ankle joint health, and patient-centered outcomes. Our central hypothesis is that a 6-week (12 sessions) gait training program with AudFB will lead to short and long-term improvements in walking, rucking, and running biomechanics, talar cartilage deformation patterns, giving way episodes and severity of symptoms.
Specific Aims:
Aim 1: Determine if a 6-week gait training with AudFB improves lower extremity biomechanics compared to a Control condition in participants with CAI.
Aim 2: Determine if a 6-week gait training with AudFB reduces talar cartilage deformation compared to a Control condition in participants with CAI.
Aim 3: Determine if a 6-week gait training with AudFB reduces ankle giving-way episodes and severity of CAI symptoms relative to a Control condition in participants with CAI.
Study Design: Specific Aims 1-3 will be addressed using a single-blinded, multi-site randomized controlled trial design with data collected at the University of Kentucky (UK) and University of North Carolina at Charlotte (UNC Charlotte) (Figure 3). Patients with CAI will be randomized to the AudFB or Control group at a 1:1 allocation ratio (n=100; 50 UK and 50 UNC Charlotte). Participants will report to the UK Sports Medicine Research Institute or the UNC Charlotte Biodynamics Research Laboratory to complete outcomes for Specific Aims 1-3 at Baseline, Post-Intervention, and 6- and 12-Month Post-Intervention sessions, which will record: 1) lower extremity biomechanics during walking, rucking, and running, 2) talar articular cartilage deformation via ultrasonography, and 3) ankle giving way and patient-reported outcomes of CAI symptom severity. The AudFB group and Control group will complete 12 sessions of supervised gait training over 6 weeks and follow the same condition-based progression design. Each session will last roughly 25 minutes and begin with 10 minutes of walking followed by 15 minutes of the designated condition for that session (walking, rucking, or running). The AudFB group will receive real-time biofeedback derived from plantar forces of the lateral foot. The control group will be instructed to walk comfortably. Both groups will wear standard neutral athletic shoes and wireless in-shoe force insoles during every intervention session for standardization of testing procedures.
Impact and Military Benefit: The Investigators expect participants with CAI in the AudFB group will exhibit improvements in patient-centered outcomes and subsequent clinician-centered outcomes regarding biomechanics and ankle joint health. These findings will signal that our novel AudFB gait training protocol is critical to short- and long-term quality of life in patients with CAI. This study will provide a short-term impact by providing clinicians with an easily accessible and feasible tool to implement gait training to optimize return to duty in service members with CAI history. The long-term impact of this study will be related to the expansion of the rehabilitation paradigm by providing an evidence-based gait training protocol that has the potential to mitigate the early onset of ankle OA.
- Conditions
- Ankle Sprains, Ankle Injuries and Disorders
- Being tested
- Walking, Rucking, Running
- Medical subject headings
- Ankle Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingOther
Weeks 1-2, Sessions 1-4: The first condition will be walking with the speed self-selected based on "a comfortable pace to walk for exercise" as determined during the Baseline testing session. This speed will be held constant for the 10-minute walking portion prior to each condition but will be progressed for the remaining walking condition sessions (Sessions 2-4). The minimum speed will be limited to 1 mph.
RuckingOther
Weeks 3-4, Session 5-8: The second condition will require participants to wear a standard rucksack equal to 20% of their body weight (minimum ruck weight: 15 pounds, maximum ruck weight: 45 pounds). The initial speed used during this condition will be self-selected based on "a comfortable pace to walk for exercise carrying this weight" as determined during the Baseline testing session.
RunningOther
Weeks 5-6, Sessions 9-12: The final condition is running. The self-selected running pace will be chosen as a pace that the participant can "sustain for a leisure run for 20 minutes," as determined at the Baseline testing session. Participants will only run for the 15-minute condition period.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control group will wear the Loadsol Pros in-shoe insoles, with the auditory biofeedback function disabled Receives: Other: Walking; Other: Rucking; Other: Running |
| auditory biofeedback (AudFB) gait training | Experimental | AudFB group will wear the Loadsol Pros in-shoe insoles with the audible noise emitted from the iOS device Receives: Other: Walking; Other: Rucking; Other: Running |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower extremity biomechanics - peak pressure
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Measured: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention
Change in lower extremity biomechanics - maximum force
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Measured: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention
Change in lower extremity biomechanics - pressure-time integral
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Measured: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention
Change in lower extremity biomechanics - force-time integral
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Measured: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention
Change in Talar cartilage deformation
Participants will be placed in a long-sitting position on a table for 30 minutes to limit the influence of the preceding activity on resting thickness volume. After the offloading period, participants will be positioned with their back flat against a wall, the test limb with the knee flexed at 90°, and their foot flat on a table. A 12-MHz linear ultrasound probe will be positioned transversely between the medial and lateral malleoli and adjusted until the talar cartilage appears to be maximum reflected. Images will be taken and averaged to assess structural and functional components of ankle joint health.
Measured: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention
Change in self perceived ankle instability
Ankle instability will be measured by the Cumberland Ankle Instability Tool (CAIT). This tool is designed to capture the severity of CAI through the 9-item scale focusing on the degree of difficulty in performing various physical activities due to the ankle. Scores range from 0 to 30, with a higher score indicative of higher stability
Measured: Baseline, 6-Month Post-Intervention, and 12-Month Post-Intervention
Change in self perceived foot and ankle disability
The Foot and Ankle Disability Index (FADI) is a region-specific patient-reported outcome designed to assess functional limitations during activities of daily living and sports-related activities in participants with foot and ankle pathologies
Measured: Baseline, 6-Month Post-Intervention, and 12-Month Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start27 May 2025
- Primary completionJun 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danielle Torp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Danielle Torp, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868316
- Sponsor's protocol ID
- 98018
- Other IDs
- CDMRP-OR230135
- Status last verified
- Jul 2026
- First submitted
- 7 Mar 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Retention on Duty in Patients With Chronic Ankle Instability Using Auditory Biofeedback Gait Training: A Multisite Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06868316
- Acronym / sponsor ID
- 98018
- Conditions
- Ankle Sprains, Ankle Injuries and Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Danielle TorpUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 10 Mar 2025 (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 goal of this randomized clinical controlled trial is examine the effects of gait training with auditory biofeedback (AudFB) on gait biomechanics, clinical measures of ankle joint health, and patient-centered outcomes. The following specific aims will achieve this objective:
- Specific Aim 1: Determine if a 6-week gait training with AudFB intervention improves lower extremity biomechanics compared to a Control condition in participants with CAI.
- Specific Aim 2: Determine if a 6-week gait training with AudFB reduces talar cartilage deformation compared to a Control condition in participants with CAI.
- Specific Aim 3: Determine if a 6-week gait training with AudFB reduces episodes of ankle giving-way and reduces self-perceived severity of symptoms relative to a Control condition in participants with CAI.
Participants will:
- Complete 12 intervention sessions over a 6-week period of walking, ruck marching, and runninig.
- Complete testing sessions before and after the intervention, then after 6 and 12-months following the intervention.
Detailed description
Background: Ankle injuries account for the highest musculoskeletal injuries among conventional and special warfare combatants. In the civilian population, 40% of lateral ankle sprain patients will develop chronic ankle instability (CAI). If the same frequency is true in military settings, then up to 36,800 service members develop CAI annually. CAI contributes to the total number of medically non-available service members, creates a substantial economic burden, impacts the quality of duty-relevant task performance, and generates a large population of service members who require long-term care after retirement. There are no evidence-based gait training interventions for patients with CAI despite abnormal biomechanical patterns leading to recurring injuries linked to ankle osteoarthritis (OA) development. Overall, the current rehabilitation strategies are insufficient for preventing complications following an ankle sprain.
Hypothesis/Objectives: The overall objective of this study is to examine the effects of gait training with auditory feedback (AudFB) on gait biomechanics, ankle joint health, and patient-centered outcomes. Our central hypothesis is that a 6-week (12 sessions) gait training program with AudFB will lead to short and long-term improvements in walking, rucking, and running biomechanics, talar cartilage deformation patterns, giving way episodes and severity of symptoms.
Specific Aims:
Aim 1: Determine if a 6-week gait training with AudFB improves lower extremity biomechanics compared to a Control condition in participants with CAI.
Aim 2: Determine if a 6-week gait training with AudFB reduces talar cartilage deformation compared to a Control condition in participants with CAI.
Aim 3: Determine if a 6-week gait training with AudFB reduces ankle giving-way episodes and severity of CAI symptoms relative to a Control condition in participants with CAI.
Study Design: Specific Aims 1-3 will be addressed using a single-blinded, multi-site randomized controlled trial design with data collected at the University of Kentucky (UK) and University of North Carolina at Charlotte (UNC Charlotte) (Figure 3). Patients with CAI will be randomized to the AudFB or Control group at a 1:1 allocation ratio (n=100; 50 UK and 50 UNC Charlotte). Participants will report to the UK Sports Medicine Research Institute or the UNC Charlotte Biodynamics Research Laboratory to complete outcomes for Specific Aims 1-3 at Baseline, Post-Intervention, and 6- and 12-Month Post-Intervention sessions, which will record: 1) lower extremity biomechanics during walking, rucking, and running, 2) talar articular cartilage deformation via ultrasonography, and 3) ankle giving way and patient-reported outcomes of CAI symptom severity. The AudFB group and Control group will complete 12 sessions of supervised gait training over 6 weeks and follow the same condition-based progression design. Each session will last roughly 25 minutes and begin with 10 minutes of walking followed by 15 minutes of the designated condition for that session (walking, rucking, or running). The AudFB group will receive real-time biofeedback derived from plantar forces of the lateral foot. The control group will be instructed to walk comfortably. Both groups will wear standard neutral athletic shoes and wireless in-shoe force insoles during every intervention session for standardization of testing procedures.
Impact and Military Benefit: The Investigators expect participants with CAI in the AudFB group will exhibit improvements in patient-centered outcomes and subsequent clinician-centered outcomes regarding biomechanics and ankle joint health. These findings will signal that our novel AudFB gait training protocol is critical to short- and long-term quality of life in patients with CAI. This study will provide a short-term impact by providing clinicians with an easily accessible and feasible tool to implement gait training to optimize return to duty in service members with CAI history. The long-term impact of this study will be related to the expansion of the rehabilitation paradigm by providing an evidence-based gait training protocol that has the potential to mitigate the early onset of ankle OA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Walking, Other: Rucking, Other: RunningControl group will wear the Loadsol Pros in-shoe insoles, with the auditory biofeedback function disabled |
| auditory biofeedback (AudFB) gait training | Experimental | Other: Walking, Other: Rucking, Other: RunningAudFB group will wear the Loadsol Pros in-shoe insoles with the audible noise emitted from the iOS device |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Physically active adults (defined as participants reporting a score of =4 on the National Aeronautics and Space Administration (NASA) Activity Instrument and indicating they can run for at least 20 consecutive minutes)
- History of ankle sprain
- 2 episodes of "giving way" in the past 6-months
- must answer "yes" to =5 questions on the Ankle Instability Instrument (AII) and =11 on the Identification of Functional Ankle Instability (IdFAI)
Key exclusion criteria (7 listed)
- an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months
- history of surgery in the lower extremity
- fracture to the lower extremity in the past 12 months or a fracture that required open-reduction internal fixation
- history of neurological disease, vestibular or visual disturbance or any other pathology that would impair sensorimotor performance or gait
- current participation in a formal ankle joint rehabilitation program
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 |
|---|---|---|
| WalkingWeeks 1-2, Sessions 1-4: The first condition will be walking with the speed self-selected based on "a comfortable pace to walk for exercise" as determined during the Baseline testing session. This speed will be held constant for the 10-minute walking portion prior to each condition but will be progressed for the remaining walking condition sessions (Sessions 2-4). The minimum speed will be limited to 1 mph. | Other | Control, auditory biofeedback (AudFB) gait training |
| RuckingWeeks 3-4, Session 5-8: The second condition will require participants to wear a standard rucksack equal to 20% of their body weight (minimum ruck weight: 15 pounds, maximum ruck weight: 45 pounds). The initial speed used during this condition will be self-selected based on "a comfortable pace to walk for exercise carrying this weight" as determined during the Baseline testing session. | Other | Control, auditory biofeedback (AudFB) gait training |
| RunningWeeks 5-6, Sessions 9-12: The final condition is running. The self-selected running pace will be chosen as a pace that the participant can "sustain for a leisure run for 20 minutes," as determined at the Baseline testing session. Participants will only run for the 15-minute condition period. | Other | Control, auditory biofeedback (AudFB) gait training |
Primary outcome
Change in lower extremity biomechanics - peak pressure
Time frame: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Change in lower extremity biomechanics - maximum force
Time frame: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Change in lower extremity biomechanics - pressure-time integral
Time frame: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Change in lower extremity biomechanics - force-time integral
Time frame: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention
The assessment will consist of a 45-minute treadmill loading protocol with 15 minutes of each: walking, running, and ruck marching.
Change in Talar cartilage deformation
Time frame: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention
Participants will be placed in a long-sitting position on a table for 30 minutes to limit the influence of the preceding activity on resting thickness volume. After the offloading period, participants will be positioned with their back flat against a wall, the test limb with the knee flexed at 90°, and their foot flat on a table. A 12-MHz linear ultrasound probe will be positioned transversely between the medial and lateral malleoli and adjusted until the talar cartilage appears to be maximum reflected. Images will be taken and averaged to assess structural and functional components of ankle joint health.
Change in self perceived ankle instability
Time frame: Baseline, 6-Month Post-Intervention, and 12-Month Post-Intervention
Ankle instability will be measured by the Cumberland Ankle Instability Tool (CAIT). This tool is designed to capture the severity of CAI through the 9-item scale focusing on the degree of difficulty in performing various physical activities due to the ankle. Scores range from 0 to 30, with a higher score indicative of higher stability
Change in self perceived foot and ankle disability
Time frame: Baseline, 6-Month Post-Intervention, and 12-Month Post-Intervention
The Foot and Ankle Disability Index (FADI) is a region-specific patient-reported outcome designed to assess functional limitations during activities of daily living and sports-related activities in participants with foot and ankle pathologies
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 21 Jul 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking, Rucking and Running in people with Ankle Sprains and Ankle Injuries and Disorders, run by Danielle Torp at 2 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 4 inclusion and 7 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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 Danielle M Torp, PhD, ATC (18593239835, danielle.torp@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lower extremity biomechanics - peak pressure (time frame: baseline, immediately following the intervention, 6 months post intervention, and 12 months post intervention). The study lists 7 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 21 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.