Adult ALLCDOKNEEpilotNCT05209360
Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics
A study testing Medial or Lateral Wedge and Carbon Fiber Custom Dynamic Orthosis in people with Adult ALL and Healthy, run by University of Iowa at 1 site in United States.
Trial summary
The proposed study evaluates the effect of medial and lateral wedges and carbon fiber custom dynamic orthoses (CDOs) on lower limb forces and motion during walking. Previous work has used foam wedges of different stiffness and height placed under the heel to alter CDO alignment and alter lower limb mechanics. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Medial or Lateral Wedge and Carbon Fiber Custom Dynamic Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Between the ages of 18 and 45
- Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months
- Able to hop without pain
- Able to perform a full squat without pain
- Ability to speak and understand English
Who cannot join
- Medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months
- Diagnosed with a moderate or severe brain injury
- Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- Injuries that would limit performance in this study
- Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
- Uncorrected visual or hearing impairment(s)
Show all 10Show fewer
- Require use of an assistive device
- Unhealed wounds (cuts/abrasions) that would prevent CDO use
- BMI > 35
- Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study evaluates the effect of medial and lateral wedges and carbon fiber custom dynamic orthoses (CDOs) on lower limb forces and motion during walking. Previous work has used foam wedges of different stiffness and height placed under the heel to alter CDO alignment and alter lower limb mechanics. Medial or lateral wedges have been used by individuals with unilateral knee osteoarthritis in effort to reduce knee loading. In this study, medial and lateral wedges will be placed in participants shoes, with the tall side of the wedge placed on the medial or lateral aspect of the shoes, and participants will walk at controlled and self-selected speeds and complete physical performance measures. Participants will also walk without a CDO. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis.
Read the detailed description
The primary purpose of this line of research is to investigate the effects of combined carbon fiber custom dynamic orthosis (CDO) and medial or lateral wedge use on biomechanics during gait in effort to reduce unilateral knee compartment loading. The medial or lateral wedges are composed of foam, run the length of the foot, and will be placed so the tall side of the wedge is on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial and lateral edges of the foot respectively. The use of medial and lateral wedges to treat unilateral knee osteoarthritis (OA) has been studied previously, generally without combined use of a foot and ankle brace such as a CDO. Previous work has demonstrated that foam wedges, of different height and stiffness, placed under the heel of a CDO affects sagittal plane gait biomechanics, including ankle plantarflexion and knee extension moments. The additional support and restriction of motion at the ankle associated with CDO use may emphasize results seen at the knee with medial or lateral wedging. Therefore, the proposed effort is designed to evaluate how different medial or lateral wedges placed under a CDO influence frontal plane knee biomechanics during level over-ground gait and physical performance during tests of agility, speed, and lower limb power. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis.
In this research study, data will be collected from a cohort of healthy adult participants with no history of lower limb injuries or functional deficits. Participants will be evaluated using a series of study measures under each of the four conditions; without a brace (NoCDO), with a brace and no wedge (CDO), with a brace and a medial wedge placed in the shoe (Medial), and with a brace and a lateral wedge placed in the shoe (Lateral). The wedge will be placed in a medial and lateral position to determine effectiveness of combined wedging and CDO use in treating both medial and lateral knee OA. Testing will be randomized for each participant. Participants will walk on a level-ground walkway at self-selected and controlled speeds. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that the CDO and wedge do not negatively affect physical function. Questionnaires will be used to evaluate participants' pain and perception of comfort and smoothness for each testing condition.
- Being tested
- Medial or Lateral Wedge, Carbon Fiber Custom Dynamic Orthosis
- Keywords
- Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics, Knee Osteoarthritis
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial or Lateral WedgeDevice
A foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot.
Carbon Fiber Custom Dynamic OrthosisDevice
Also called CDO
A device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Testing Order: NoCDO, CDO, Lateral, Medial Receives: Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis |
| Arm 2 | Experimental | Testing Order: NoCDO, CDO, Medial, Lateral Receives: Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis |
| Arm 3 | Experimental | Testing Order: NoCDO, Medial, CDO, Lateral Receives: Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis |
| Arm 4 | Experimental | Testing Order: NoCDO, Medial, Lateral, CDO Receives: Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis |
| Arm 5 | Experimental | Testing Order: NoCDO, Lateral, Medial, CDO Receives: Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis |
| Arm 6 | Experimental | Testing Order: NoCDO, Lateral, CDO, Medial Receives: Device: Medial or Lateral Wedge; Device: Carbon Fiber Custom Dynamic Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Range of Motion
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) were used to evaluate the motion of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Sagittal plane knee range of motion (degrees) was measured throughout the gait cycle.
Measured: Baseline
Peak Knee Moment
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) and three force plates (1200Hz, AMTI Inc., Watertown, MA) were used to evaluate the motion and loading of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Peak knee valgus moment was measured during stance phase and normalized to the participants body weight (Nm/kg).
Measured: Baseline
Four Square Step Test (4SST)
The 4SST (s) is a standardized timed test of balance and agility. Participants start in the lower left quadrant of a Maltese cross setting on the floor and are timed as they move counterclockwise (forward, right, backward, left) and then clockwise (right, forward, left, backward) around the cross. Participants are instructed to move as quickly as they safely can.
Measured: Baseline
Numerical Pain Rating Scale
Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable.
Measured: Baseline
Modified Socket Comfort Score (Comfort)
Participants were asked to rate the comfort of each braced condition (CDO Only, Medial, Lateral) on a scale from 0-10 with 0 = most uncomfortable to 10 = most comfortable.
Measured: Baseline
Modified Socket Comfort Score (Smoothness)
Participants were asked to rate the smoothness of each braced condition (CDO Only, Medial, Lateral) on a scale from 0-10 with 0 = most smooth to 10 = least smooth.
Measured: Baseline
Secondary outcomes (4)
Ankle Range of Motion
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) were used to evaluate the motion of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Sagittal plane ankle range of motion (degrees) was measured throughout the gait cycle.
Measured: Baseline
Peak Ankle Moment
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) and three force plates (1200Hz, AMTI Inc., Watertown, MA) were used to evaluate the motion and loading of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Peak ankle plantarflexor moment was measured during stance phase and normalized to the participants body weight (Nm/kg).
Measured: Baseline
Peak Ankle Power
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) and three force plates (1200Hz, AMTI Inc., Watertown, MA) were used to evaluate the motion and loading of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Peak ankle push-off power was measured during stance phase and normalized to the participants body weight (W/kg).
Measured: Baseline
Sit to Stand 5 Times (STS5)
STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are timed as they stand up and sit down 5 times as fast as possible.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start9 May 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult ALLStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be evaluated without a CDO (NoCDO), with a CDO and no wedge (CDO), with a CDO and a wedge placed on the medial aspect of the shoe (Medial), and with a CDO and a wedge placed on the lateral aspect of the shoe (Lateral)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Wilken, University of Iowa
- Investigators
- Jason M Wilken, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209360
- Sponsor's protocol ID
- 202112360
- Acronym
- CDOKNEEpilot
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2022
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heel Wedges and Carbon Fiber Custom Dynamic Orthoses to Control Knee Biomechanics
- ClinicalTrials.gov ID
- NCT05209360
- Acronym / sponsor ID
- CDOKNEEpilot / 202112360
- Keywords
- Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study evaluates the effect of medial and lateral wedges and carbon fiber custom dynamic orthoses (CDOs) on lower limb forces and motion during walking. Previous work has used foam wedges of different stiffness and height placed under the heel to alter CDO alignment and alter lower limb mechanics. Medial or lateral wedges have been used by individuals with unilateral knee osteoarthritis in effort to reduce knee loading. In this study, medial and lateral wedges will be placed in participants shoes, with the tall side of the wedge placed on the medial or lateral aspect of the shoes, and participants will walk at controlled and self-selected speeds and complete physical performance measures. Participants will also walk without a CDO. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis.
Detailed description
The primary purpose of this line of research is to investigate the effects of combined carbon fiber custom dynamic orthosis (CDO) and medial or lateral wedge use on biomechanics during gait in effort to reduce unilateral knee compartment loading. The medial or lateral wedges are composed of foam, run the length of the foot, and will be placed so the tall side of the wedge is on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial and lateral edges of the foot respectively. The use of medial and lateral wedges to treat unilateral knee osteoarthritis (OA) has been studied previously, generally without combined use of a foot and ankle brace such as a CDO. Previous work has demonstrated that foam wedges, of different height and stiffness, placed under the heel of a CDO affects sagittal plane gait biomechanics, including ankle plantarflexion and knee extension moments. The additional support and restriction of motion at the ankle associated with CDO use may emphasize results seen at the knee with medial or lateral wedging. Therefore, the proposed effort is designed to evaluate how different medial or lateral wedges placed under a CDO influence frontal plane knee biomechanics during level over-ground gait and physical performance during tests of agility, speed, and lower limb power. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis.
In this research study, data will be collected from a cohort of healthy adult participants with no history of lower limb injuries or functional deficits. Participants will be evaluated using a series of study measures under each of the four conditions; without a brace (NoCDO), with a brace and no wedge (CDO), with a brace and a medial wedge placed in the shoe (Medial), and with a brace and a lateral wedge placed in the shoe (Lateral). The wedge will be placed in a medial and lateral position to determine effectiveness of combined wedging and CDO use in treating both medial and lateral knee OA. Testing will be randomized for each participant. Participants will walk on a level-ground walkway at self-selected and controlled speeds. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that the CDO and wedge do not negatively affect physical function. Questionnaires will be used to evaluate participants' pain and perception of comfort and smoothness for each testing condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Participants will be evaluated without a CDO (NoCDO), with a CDO and no wedge (CDO), with a CDO and a wedge placed on the medial aspect of the shoe (Medial), and with a CDO and a wedge placed on the lateral aspect of the shoe (Lateral)
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Medial or Lateral Wedge, Device: Carbon Fiber Custom Dynamic OrthosisTesting Order: NoCDO, CDO, Lateral, Medial |
| Arm 2 | Experimental | Device: Medial or Lateral Wedge, Device: Carbon Fiber Custom Dynamic OrthosisTesting Order: NoCDO, CDO, Medial, Lateral |
| Arm 3 | Experimental | Device: Medial or Lateral Wedge, Device: Carbon Fiber Custom Dynamic OrthosisTesting Order: NoCDO, Medial, CDO, Lateral |
| Arm 4 | Experimental | Device: Medial or Lateral Wedge, Device: Carbon Fiber Custom Dynamic OrthosisTesting Order: NoCDO, Medial, Lateral, CDO |
| Arm 5 | Experimental | Device: Medial or Lateral Wedge, Device: Carbon Fiber Custom Dynamic OrthosisTesting Order: NoCDO, Lateral, Medial, CDO |
| Arm 6 | Experimental | Device: Medial or Lateral Wedge, Device: Carbon Fiber Custom Dynamic OrthosisTesting Order: NoCDO, Lateral, CDO, Medial |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 18 and 45
- Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months
- Able to hop without pain
- Able to perform a full squat without pain
- Ability to speak and understand English
Key exclusion criteria (10 listed)
- Medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months
- Diagnosed with a moderate or severe brain injury
- Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- Injuries that would limit performance in this study
- Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
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 |
|---|---|---|
| Medial or Lateral WedgeA foam wedge that is placed inside the shoe under the CDO, that runs along the length of the foot. The tall side of the wedge will be placed on the medial (Medial Wedge) or lateral (Lateral Wedge) aspect of the shoe to preferentially load the medial or lateral side of the foot. | Device | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
| Carbon Fiber Custom Dynamic OrthosisAlso: CDOA device that consists of a proximal cuff that wraps around the leg just below the knee, a posterior strut that runs the length of the leg, and a semi-rigid footplate that goes under the length of the foot. | Device | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
Primary outcome
Knee Range of Motion
Time frame: Baseline
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) were used to evaluate the motion of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Sagittal plane knee range of motion (degrees) was measured throughout the gait cycle.
Peak Knee Moment
Time frame: Baseline
Participants completed a biomechanical gait analysis session in all testing conditions (NoCDO, CDO Only, Medial, Lateral). Retro-reflective markers were placed on the participants skin and 12 infrared motion capture cameras (120Hz, Vicon Ltd., Oxford, UK) and three force plates (1200Hz, AMTI Inc., Watertown, MA) were used to evaluate the motion and loading of the lower limb as participants walked at a controlled walking speed based on leg length. A minimum of three gait cycles were used to calculate mean(SD) values. Peak knee valgus moment was measured during stance phase and normalized to the participants body weight (Nm/kg).
Four Square Step Test (4SST)
Time frame: Baseline
The 4SST (s) is a standardized timed test of balance and agility. Participants start in the lower left quadrant of a Maltese cross setting on the floor and are timed as they move counterclockwise (forward, right, backward, left) and then clockwise (right, forward, left, backward) around the cross. Participants are instructed to move as quickly as they safely can.
Numerical Pain Rating Scale
Time frame: Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable.
Modified Socket Comfort Score (Comfort)
Time frame: Baseline
Participants were asked to rate the comfort of each braced condition (CDO Only, Medial, Lateral) on a scale from 0-10 with 0 = most uncomfortable to 10 = most comfortable.
Modified Socket Comfort Score (Smoothness)
Time frame: Baseline
Participants were asked to rate the smoothness of each braced condition (CDO Only, Medial, Lateral) on a scale from 0-10 with 0 = most smooth to 10 = least smooth.
4 secondary outcomes
Ankle Range of Motion
Time frame: Baseline
Peak Ankle Moment
Time frame: Baseline
Peak Ankle Power
Time frame: Baseline
Sit to Stand 5 Times (STS5)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Jason M Wilken principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medial or Lateral Wedge and Carbon Fiber Custom Dynamic Orthosis in people with Adult ALL and Healthy, run by University of Iowa 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 5 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: finished, as of the sponsor's last update on 30 Jan 2024. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Range of Motion (time frame: Baseline). The study lists 6 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 30 Jan 2024.