Amputation, Lower LimbNCT05287646
Quantifying Bone and Skin Movement in the Residual Limb of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray
A study testing Suction Suspension First and Elevated Vacuum Suspension First in people with Amputation, Lower Limb, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Lower Limb
- What is being tested?
- Suction Suspension First and Elevated Vacuum Suspension First
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2024to 31 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral transtibial amputation (any etiology)
- At least 18 years old
- At least 6-months post-amputation
- Current prosthetic users (at least 6 hours/day)
Who cannot join
- Unable to ambulate on a treadmill at low to moderate speed
- Inability to tolerate the socket suspensions
- Length of the residual limb prohibits socket fitting, dynamic stereo x-ray data capture, or marker placement
- Mental impairment that impedes study compliance
- Skin conditions (i.e. burns or poor skin coverage) as well as those with severe contractures that prevent prior prosthetic wear
- Severe neuropathy, uncontrolled diabetes, have insensate foot, severe phantom pain, or a significant history of skin ulcers
Show all 10Show fewer
- Any other significant comorbidity that would interfere with the study
- Severe circulatory problems including peripheral vascular disease and pitting edema
- Cognitive deficits or mental health problems that would limit ability to participate fully in the study protocol
- Women who are pregnant or who plan to become pregnant during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
Jason Maikos, PhD, 212-686-7500 ext. 7482, Jason.Maikos@va.gov
Michael J Hyre, MS, (212) 686-7500 ext. 3339, michael.hyre@va.gov
About this study
Official title: Quantifying Bone and Skin Movement in the Residual Limb-Socket Interface of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray
Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Different prosthetic suspension systems have been developed to decrease this motion, including elevated vacuum suspension, which utilizes a pump to draw air from the socket. However, scientific analyses to understand the movement between the limb and socket have yet to be performed with a high level of accuracy. This study will use a state-of-the art imaging technique, known as dynamic stereo x-ray, to quantify the 3D movement of the residual limb in the socket. It is hypothesized that dynamic stereo x-ray will be a sensitive method to measure differences in residual limb movement between 2 different socket suspension techniques: suction and elevated vacuum suspension. This information is critical for advancing prosthetic treatments to reduce secondary conditions and degenerative changes that result from poor prosthetic fit.
Read the detailed description
Individuals with lower extremity amputation (LEA) often experience relative motion between their residual limb and the prosthetic socket, such as vertical translation and axial rotation, which can cause inefficient dynamic load transmission from the distal prosthetic components to the residual limb. This can lead to significant secondary consequences, such as pain, gait deviations, and discomfort that limit mobility and autonomy. Assessments of the relative motion between the bone and the prosthetic socket have been performed, but there is little existing data on dynamic, in vivo residual limb-socket kinematics since most investigations have been performed using non-dynamic testing protocols, static measurements, or with unvalidated surface marker-based motion capture systems. Dynamic Stereo X-ray (DSX) is an advanced imaging technology that can quantify 3D bone movement and tissue/liner deformation inside a prosthetic socket during dynamic activities.
There is a substantial gap in our understanding of the complex mechanics of the residual limb-socket interface during dynamic activities that limit the ability to improve prosthetic design. The goals for this project are to develop the analytical tools to quantify both the dynamic, in-vivo kinematics between the residual limb and socket, as well as the mechanism of residual tissue/liner deformation. In order to validate the sensitivity of this methodology to differences in socket suspension, 2 suspension systems will be evaluated: elevated vacuum and traditional suction. It is hypothesized that an efficient and highly accurate method to quantify the dynamic interaction between the residual limb and prosthetic socket will be sensitive enough to distinguish between different types of prosthetic socket suspension, which will further the biomechanical understanding of socket design. To do so, the investigators will address the following aims: (1) To optimize the DSX procedural setup for the accurate tracking of the prosthetic socket, skeletal kinematics, and tissue/liner deformation; (2) To quantify the relative motion between the residual tibia and the prosthetic socket during dynamic activities; and (3) To measure the deformation of the skin and liner in the prosthetic socket during dynamic activities.
Twenty-one participants with transtibial amputation will be fit with a socket capable of being suspended via both elevated vacuum and traditional suction. Participants will undergo a 4-week acclimation period and then be tested at the DSX facility. DSX will be utilized to track skeletal and skin/liner motion under both suspension techniques during 3 dynamic activities: treadmill walking at self-selected speed, fast walking (10% faster), and a step-down movement. The performance of the two suspension techniques (active EV and traditional suction) will be tested by quantifying the 3D bone movement of the residual tibia with respect to the prosthetic socket and quantifying liner and soft tissue deformation at the socket-residuum interface.
By using the analytical tools for a highly accurate, in-vivo assessment of residual limb-socket motion, vital foundational information can be provided to aid in the development of new methods and techniques to enhance prosthetic fit that have the potential to reduce secondary physical comorbidities and degenerative changes that result from complications of poor prosthetic load transmission.
- Conditions
- Amputation, Lower Limb
- Being tested
- Suction Suspension First, Elevated Vacuum Suspension First
- Keywords
- Prosthesis Fitting, Prosthetic Suspension Systems, Dynamic Stereo X-Ray, Biplanar Fluoroscopy, Transtibial Amputation, Pistoning, Elevated Vacuum Suspension, Suction Suspension, Lower Extremity Amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction Suspension FirstDevice
Participants will be fit with a socket capable of being suspended by both traditional suction and elevated vacuum. Participants will be assessed first with the elevated vacuum system inactive (traditional suction). Residual limb kinematics and skin deformation during movement tasks will be evaluated utilizing dynamic stereo x-ray. The evaluation will then be repeated with the elevated vacuum system active.
Elevated Vacuum Suspension FirstDevice
Participants will be fit with a socket capable of being suspended by both traditional suction and elevated vacuum. Participants will be assessed first with the elevated vacuum system active. Residual limb kinematics and skin deformation during movement tasks will be evaluated utilizing dynamic stereo x-ray. The evaluation will then be repeated with the elevated vacuum system inactive.
| Study group | Role | What they receive |
|---|---|---|
| Suction Suspension First | Active comparator | The residual limb will be imaged during dynamic activities while participants use suction suspension first, then while participants use elevated vacuum suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting. Receives: Device: Suction Suspension First |
| Elevated Vacuum Suspension First | Active comparator | The residual limb will be imaged during dynamic activities while participants use elevated vacuum suspension first, then while participants use suction suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting. Receives: Device: Elevated Vacuum Suspension First |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dynamic residual tibia kinematics between suspension techniques
To evaluate the 6 degree of freedom kinematics of the residual limb within the socket, participants with transtibial amputation will walk on a treadmill at a self-selected speed, at a speed 10% faster than their self-selected speed, and also perform a step-down task from an 18 cm high platform. These movement tasks will be completed under 2 conditions: with the elevated suspension active and with the elevated system inactive (traditional suction). Up to 4 trials of dynamic stereo x-ray will be conducted for each task for each socket condition. For each task, dynamic stereo x-ray data will be collected and analyzed to determine underlying bone movement with respect to the socket. Six degree of freedom residual tibia rotations and translations relative to the prosthetic socket will be measured.
Measured: 4 weeks post socket fit
Changes in dynamic skin deformation of the residual limb between suspension techniques
Radio-opaque markers will be placed on the residual limb in specific patterns. Participants will walk on a treadmill at a self-selected speed, at a speed 10% faster than their self-selected speed, and also perform a step-down task from an 18 cm high platform. These movement tasks will be completed under 2 conditions: with the elevated suspension active and with the elevated system inactive (traditional suction). Up to 4 trials of dynamic stereo x-ray will be conducted for each task for each socket condition. For each task, dynamic stereo x-ray data will be collected and analyzed to determine underlying skin deformation. The radio-opaque markers on the skin will be tracked during the dynamic trials, and their trajectories in the socket coordinate system will define the motion of the skin relative to the socket. Shear, defined as the change in angle between the markers, and compression, defined as the change in distance between markers and a neutral position, will be calculated.
Measured: 4 weeks post socket fit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start5 Jan 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amputation, Lower LimbStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, block, cross-over design will be used to evaluate the residual limb-socket fit. A group of 11 (Group 1) and a group of 10 (Group 2) participants will be formed. Participants in Group 1 will first be tested with the elevated vacuum system active and then repeat all procedures with the elevated vacuum system inactive. Participants in Group 2 will first be tested with the elevated vacuum system inactive and then repeat the tasks with the elevated vacuum system active.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Rutgers University, University of Rhode Island
- Responsible party
- Sponsor
- Investigators
- Jason Maikos, PhD, Principal investigator, VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287646
- Sponsor's protocol ID
- A3700-R
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2022
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be stored in a curated data repository that makes the data underlying scientific publications discoverable, freely usable, and citable, while promoting openly available research integrated with scholarly literature.
Publications
Paglia DN, Chomack JM, Herlihy DV, Wetterstrand C, Kadkoy Y, Duchnycz R, Kelly P, O'Connor JP, D'Andrea SE, Maikos JT. Mitigation of image distortion during mechanical testing within a dynamic stereo x-ray system. Front Bioeng Biotechnol. 2025 May 19;13:1571639. doi: 10.3389/fbioe.2025.1571639. eCollection 2025.
PubMed 40458257Maikos JT, Chomack JM, Herlihy DV, Paglia DN, Wetterstrand C, O'Connor JP, Hyre MJ, Loan JP, D'Andrea SE. Quantifying Bone and Skin Movement in the Residual Limb-Socket Interface of Individuals With Transtibial Limb Loss Using Dynamic Stereo X-Ray: Protocol for a Lower Limb Loss Cadaver and Clinical Study. JMIR Res Protoc. 2024 Apr 26;13:e57329. doi: 10.2196/57329.
PubMed 38669065
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Bone and Skin Movement in the Residual Limb-Socket Interface of Individuals With Transtibial Amputation Using Dynamic Stereo X-Ray
- ClinicalTrials.gov ID
- NCT05287646
- Acronym / sponsor ID
- A3700-R
- Conditions
- Amputation, Lower Limb
- Keywords
- Prosthesis Fitting, Prosthetic Suspension Systems, Dynamic Stereo X-Ray, Biplanar Fluoroscopy, Transtibial Amputation, Pistoning, Elevated Vacuum Suspension, Suction Suspension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Rutgers University, University of Rhode Island
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 18 Mar 2022 (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.
Individuals with lower extremity amputation are often challenged by complications that arise from poor prosthetic fit, including movement of the residual limb in the socket, known as pistoning. Pistoning can lead to gait instability, skin problems, and pain. Different prosthetic suspension systems have been developed to decrease this motion, including elevated vacuum suspension, which utilizes a pump to draw air from the socket. However, scientific analyses to understand the movement between the limb and socket have yet to be performed with a high level of accuracy. This study will use a state-of-the art imaging technique, known as dynamic stereo x-ray, to quantify the 3D movement of the residual limb in the socket. It is hypothesized that dynamic stereo x-ray will be a sensitive method to measure differences in residual limb movement between 2 different socket suspension techniques: suction and elevated vacuum suspension. This information is critical for advancing prosthetic treatments to reduce secondary conditions and degenerative changes that result from poor prosthetic fit.
Detailed description
Individuals with lower extremity amputation (LEA) often experience relative motion between their residual limb and the prosthetic socket, such as vertical translation and axial rotation, which can cause inefficient dynamic load transmission from the distal prosthetic components to the residual limb. This can lead to significant secondary consequences, such as pain, gait deviations, and discomfort that limit mobility and autonomy. Assessments of the relative motion between the bone and the prosthetic socket have been performed, but there is little existing data on dynamic, in vivo residual limb-socket kinematics since most investigations have been performed using non-dynamic testing protocols, static measurements, or with unvalidated surface marker-based motion capture systems. Dynamic Stereo X-ray (DSX) is an advanced imaging technology that can quantify 3D bone movement and tissue/liner deformation inside a prosthetic socket during dynamic activities.
There is a substantial gap in our understanding of the complex mechanics of the residual limb-socket interface during dynamic activities that limit the ability to improve prosthetic design. The goals for this project are to develop the analytical tools to quantify both the dynamic, in-vivo kinematics between the residual limb and socket, as well as the mechanism of residual tissue/liner deformation. In order to validate the sensitivity of this methodology to differences in socket suspension, 2 suspension systems will be evaluated: elevated vacuum and traditional suction. It is hypothesized that an efficient and highly accurate method to quantify the dynamic interaction between the residual limb and prosthetic socket will be sensitive enough to distinguish between different types of prosthetic socket suspension, which will further the biomechanical understanding of socket design. To do so, the investigators will address the following aims: (1) To optimize the DSX procedural setup for the accurate tracking of the prosthetic socket, skeletal kinematics, and tissue/liner deformation; (2) To quantify the relative motion between the residual tibia and the prosthetic socket during dynamic activities; and (3) To measure the deformation of the skin and liner in the prosthetic socket during dynamic activities.
Twenty-one participants with transtibial amputation will be fit with a socket capable of being suspended via both elevated vacuum and traditional suction. Participants will undergo a 4-week acclimation period and then be tested at the DSX facility. DSX will be utilized to track skeletal and skin/liner motion under both suspension techniques during 3 dynamic activities: treadmill walking at self-selected speed, fast walking (10% faster), and a step-down movement. The performance of the two suspension techniques (active EV and traditional suction) will be tested by quantifying the 3D bone movement of the residual tibia with respect to the prosthetic socket and quantifying liner and soft tissue deformation at the socket-residuum interface.
By using the analytical tools for a highly accurate, in-vivo assessment of residual limb-socket motion, vital foundational information can be provided to aid in the development of new methods and techniques to enhance prosthetic fit that have the potential to reduce secondary physical comorbidities and degenerative changes that result from complications of poor prosthetic load transmission.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, block, cross-over design will be used to evaluate the residual limb-socket fit. A group of 11 (Group 1) and a group of 10 (Group 2) participants will be formed. Participants in Group 1 will first be tested with the elevated vacuum system active and then repeat all procedures with the elevated vacuum system inactive. Participants in Group 2 will first be tested with the elevated vacuum system inactive and then repeat the tasks with the elevated vacuum system active.
| Arm | Type | Receives |
|---|---|---|
| Suction Suspension First | Active comparator | Device: Suction Suspension FirstThe residual limb will be imaged during dynamic activities while participants use suction suspension first, then while participants use elevated vacuum suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting. |
| Elevated Vacuum Suspension First | Active comparator | Device: Elevated Vacuum Suspension FirstThe residual limb will be imaged during dynamic activities while participants use elevated vacuum suspension first, then while participants use suction suspension. Dynamic stereo x-ray will take place 4-weeks after socket fitting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral transtibial amputation (any etiology)
- At least 18 years old
- At least 6-months post-amputation
- Current prosthetic users (at least 6 hours/day)
Key exclusion criteria (10 listed)
- Unable to ambulate on a treadmill at low to moderate speed
- Inability to tolerate the socket suspensions
- Length of the residual limb prohibits socket fitting, dynamic stereo x-ray data capture, or marker placement
- Mental impairment that impedes study compliance
- Skin conditions (i.e. burns or poor skin coverage) as well as those with severe contractures that prevent prior prosthetic wear
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 |
|---|---|---|
| Suction Suspension FirstParticipants will be fit with a socket capable of being suspended by both traditional suction and elevated vacuum. Participants will be assessed first with the elevated vacuum system inactive (traditional suction). Residual limb kinematics and skin deformation during movement tasks will be evaluated utilizing dynamic stereo x-ray. The evaluation will then be repeated with the elevated vacuum system active. | Device | Suction Suspension First |
| Elevated Vacuum Suspension FirstParticipants will be fit with a socket capable of being suspended by both traditional suction and elevated vacuum. Participants will be assessed first with the elevated vacuum system active. Residual limb kinematics and skin deformation during movement tasks will be evaluated utilizing dynamic stereo x-ray. The evaluation will then be repeated with the elevated vacuum system inactive. | Device | Elevated Vacuum Suspension First |
Primary outcome
Changes in dynamic residual tibia kinematics between suspension techniques
Time frame: 4 weeks post socket fit
To evaluate the 6 degree of freedom kinematics of the residual limb within the socket, participants with transtibial amputation will walk on a treadmill at a self-selected speed, at a speed 10% faster than their self-selected speed, and also perform a step-down task from an 18 cm high platform. These movement tasks will be completed under 2 conditions: with the elevated suspension active and with the elevated system inactive (traditional suction). Up to 4 trials of dynamic stereo x-ray will be conducted for each task for each socket condition. For each task, dynamic stereo x-ray data will be collected and analyzed to determine underlying bone movement with respect to the socket. Six degree of freedom residual tibia rotations and translations relative to the prosthetic socket will be measured.
Changes in dynamic skin deformation of the residual limb between suspension techniques
Time frame: 4 weeks post socket fit
Radio-opaque markers will be placed on the residual limb in specific patterns. Participants will walk on a treadmill at a self-selected speed, at a speed 10% faster than their self-selected speed, and also perform a step-down task from an 18 cm high platform. These movement tasks will be completed under 2 conditions: with the elevated suspension active and with the elevated system inactive (traditional suction). Up to 4 trials of dynamic stereo x-ray will be conducted for each task for each socket condition. For each task, dynamic stereo x-ray data will be collected and analyzed to determine underlying skin deformation. The radio-opaque markers on the skin will be tracked during the dynamic trials, and their trajectories in the socket coordinate system will define the motion of the skin relative to the socket. Shear, defined as the change in angle between the markers, and compression, defined as the change in distance between markers and a neutral position, will be calculated.
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 22 Apr 2026.
- Derived from this study: PubMed 40458257Paglia DN, Chomack JM, Herlihy DV, Wetterstrand C, Kadkoy Y, Duchnycz R, Kelly P, O'Connor JP, D'Andrea SE, Maikos JT. Mitigation of image distortion during mechanical testing within a dynamic stereo x-ray system. Front Bioeng Biotechnol. 2025 May 19;13:1571639. doi: 10.3389/fbioe.2025.1571639. eCollection 2025.
- Derived from this study: PubMed 38669065Maikos JT, Chomack JM, Herlihy DV, Paglia DN, Wetterstrand C, O'Connor JP, Hyre MJ, Loan JP, D'Andrea SE. Quantifying Bone and Skin Movement in the Residual Limb-Socket Interface of Individuals With Transtibial Limb Loss Using Dynamic Stereo X-Ray: Protocol for a Lower Limb Loss Cadaver and Clinical Study. JMIR Res Protoc. 2024 Apr 26;13:e57329. doi: 10.2196/57329.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be stored in a curated data repository that makes the data underlying scientific publications discoverable, freely usable, and citable, while promoting openly available research integrated with scholarly literature.
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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.
Jason Maikos, PhD principal investigator
VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suction Suspension First and Elevated Vacuum Suspension First in people with Amputation, Lower Limb, run by VA Office of Research and Development at 1 site 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 10 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 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jason Maikos, PhD ((212) 686-7500 ext. 7482, Jason.Maikos@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in dynamic residual tibia kinematics between suspension techniques (time frame: 4 weeks post socket fit). 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?
On the ClinicalTrials.gov record for NCT05287646, which also lists 2 linked publications.
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 22 Apr 2026.