Flatfoot, FlexibleNCT05840965
The Effect of Foot Core Exercises or Foot Orthotics in Symptomatic Flexible Flatfoot
A study testing Foot muscle strengthening and Foot orthotics in people with Flatfoot, Flexible, run by KU Leuven at 1 site in Belgium.
Trial summary
The overall goal of this study is to evaluate the effect of a foot strengthening program (focused on the intrinsic foot muscles) on ankle and foot joint kinematics and kinetics (rearfoot, midfoot, and forefoot) in patients with symptomatic flexible flat feet. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Flatfoot, Flexible
- What is being tested?
- Foot muscle strengthening and Foot orthotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For both asymptomatic and symptomatic flexible flatfoot:
- Adults between 18 and 65 years of age, able to run at a self- selected low speed.
- Physically active: min. 1h30 and max 6 h/week
- Foot Posture Index > 6 AND Navicular drop > 5 mm
- Informed consent (ICF) obtained
- For asymptomatic flexible flatfoot:
Show all 17Show fewer
- cfr. supra
- For symptomatic flexible flatfoot:
- Diagnosis made by a physician
- ICF obtained
- Symptomatic =
- Foot pain ( > 4 on Visual Analog Pain Scale score) OR
- Medial arch pain OR
- Metatarsalgia (general or diffuse hyperkeratosis accepted) OR
- Lateral impingement pain OR
- Sinus tarsi pain OR
- Tibialis posterior dysfunction stage I and II (without indication of rupture) and painful single heel raise test
Who cannot join
- For both groups:
- < 18 years, > 65 years
- Any medical contraindication to physical exertion
- Systemic diseases
- Recent lower limb surgery (< 6 months)
- Lower limb osteosynthesis material
Show all 15Show fewer
- Pregnancy
- Pacemaker
- Leg length discrepancy > 3 cm
- Body Mass Index (BMI) > 30kg/m²
- Constant ankle pain
- Ankle fractures
- Single hyperkeratotic lesion with nucleus under metatarsal head
- Recent participation in a physical rehabilitation program (< 3 months)
- Recent orthotics (< 3 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Foot Biomechanics and the Effect of Foot Core Exercises or Foot Orthotics in Symptomatic Flexible Flatfoot
The overall goal of this study is to evaluate the effect of a foot strengthening program (focused on the intrinsic foot muscles) on ankle and foot joint kinematics and kinetics (rearfoot, midfoot, and forefoot) in patients with symptomatic flexible flat feet. The investigators will also evaluate the effect on intrinsic muscle morphology, foot strength, pain and other symptoms. The investigators will compare to the standard conservative therapy, which is foot orthotic therapy.
Read the detailed description
A common condition is "symptomatic flexible flat foot". This clinical entity affects 1 in 5 adults and is characterized by misalignment of the foot joints, resulting in a flat medial longitudinal foot arch. As a result, the foot's load-bearing capacity is reduced, leading to overuse injuries such as back pain, patellofemoral pain, or medial tibial stress syndrome.
The literature shows that people with flexible flat feet have disturbed foot and ankle kinematics during locomotor tasks. However, the current literature lacks insight into the kinetics of the foot joints (i.e., forces that cause joint movement) during both relatively simple tasks such as walking and running and more challenging tasks such as landing from a step. The recent development of multisegmental kinetic foot models allows for detailed information to be obtained regarding (mal)adaptive joint loading patterns in this population and address shortcomings in the current literature.
In recent years, the small intrinsic foot muscles (IFM) have received more attention in the treatment of foot and ankle-related overuse injuries, such as plantar fasciitis, medial tibial stress syndrome, and Achilles tendinopathy. According to the "foot core" paradigm, the primary role of the intrinsic foot muscles is to support the medial foot arch. They contribute to the absorptive and generative capacity of the medial foot arch and work together with the plantar aponeurosis, ligaments, and extrinsic foot muscles. It is known that their strength and volume are reduced in people with flat feet.
A randomized controlled trial will be planned in which participants with symptomatic flexible flatfeet will be allocated to either receiving foot core strengthening exercises or custom made foot orthotics therapy. An asymptomatic group with flexible flatfeet will serve as a control group and will not undergo any intervention.
Primary objective 1: To evaluate changes in foot joint kinetics and kinematics and intrinsic foot muscle size following a foot core strengthening program in participants with symptomatic flexible flatfoot and whether this is different to the control therapy.
Secondary objective 1: To evaluate changes in foot posture, foot muscle strength, psychological scores, pain and symptoms following a foot core strengthening program and whether these changes are different in comparison to the control therapy.
Secondary objective 2: To evaluate changes in foot joint kinematics and kinetics and intrinsic foot muscle size between participants with asymptomatic and symptomatic flexible flatfoot.
- Conditions
- Flatfoot, Flexible
- Being tested
- Foot muscle strengthening, Foot orthotics
- Keywords
- Multi segment foot kinetics, Multi segment foot kinematics, Intrinsic foot muscles, Ultrasound
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot muscle strengtheningOther
A specific training program emphasizing the neuromuscular recruitment of the plantar intrinsic foot muscles. This will be colloquially referred to as the "Foot Core Strengthening Program". The exercises are: short foot exercise, toe spread out, first toe extension, second to fifth toe extension. Simultaneously, neuromuscular electrical stimulation (NMES) will be provided, as 77% of healthy active people struggle performing contractions of the foot muscles.
Foot orthoticsOther
Custom-made foot orthotics
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic flexible flatfoot | No intervention | This group undergoes no intervention. |
| Symptomatic flexible flatfoot: foot core strengthening | Experimental | The investigators put together a specific training program emphasizing the neuromuscular recruitment of the plantar intrinsic foot muscles. This will be colloquially referred to as the "Foot Core Strengthening Program". The most recognized exercise of our program is the short foot exercise. However, as recently other exercises were validated by Gooding et al., we also included following exercises: toe spread out, first-toe extension and second- to fifth-toes extension. Simultaneously, neuromuscular electrical stimulation (NMES) will be provided, as 77% of healthy active people struggle performing contractions of the foot muscles. Receives: Other: Foot muscle strengthening |
| Symptomatic flexible flatfoot: foot orthotics | Active comparator | Custom-made foot orthotics are the current standard of care (SOC) therapy within this population. Patients choose their own health care provider to customize these orthotics. The sole is made of EVA material whose color and hardness is determined by the podiatrist or bandage maker. Digital scans or plaster of Paris cast will be taken of the participant's non-weightbearing foot (placed in a neutral or corrected position) by a certified pedorthist following the prescription of the orthopaedic surgeon.
The geometry of the foot orthotic will encompass a total contact principle with respect to the medial arch. The orthotics will be manufactured using ethyl vinyl acetate (EVA) with a shore ranging between 45 and 60 Receives: Other: Foot orthotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower limb joint angles (degrees)
Joint angles will be measured based on the position of passive markers placed on participants' anatomical landmarks all over the lower limbs. The position of those markers will be tracked by 10 infrared high-speed cameras that surround the walkway (sampled at 100 Hertz (Hz) - type T-10, 1 megapixel, captures 10-bit grayscale using 1120 * 896 pixels, Vicon Motion System Ltd, Oxford, Metrics, UK).
The angular positions of the multiple joints that constitute the lower limb (hip, knee, ankle, chopart, lisfranc and metatarsophalangeal) will be assessed during walking, running, and single leg drop jump in the gait laboratory.
Measured: 8-week intervention period
Change in lower limb joint angular velocities (degrees/second)
Joint angular velocities are also assessed based on reflexive markers placed on anatomical landmarks. This outcome evaluates the rate of change of a certain joint angle over time.
Joint angular velocities will be assessed of the multiple joints that constitute the lower limb (hip, knee, ankle, chopart, lisfranc and metatarsophalangeal) during walking, running and a single leg drop jump in the gait laboratory.
Measured: 8-week intervention period
Change in joint moments
Joint moments will be determined by coupling kinematic data (joint position and velocities) with plantar pressure data from a specially designed pressure plate (sampled at 200Hz, Footscan, dimension 0.5m x 0.4m, 4096 sensors, 2.8 sensors/cm², RsScan International, Olen, Belgium) embedded in the middle of the runway and placed on top of a force plate (sampled at 1000Hz, Advanced Mechanical Technology Inc., Watertown, MA, USA). Kinetic data will be assessed while walking, running and a single leg drop jump in the gait laboratory.
Measured: 8-week intervention period
Change in foot muscle thickness
The thickness of five intrinsic foot muscles (abductor hallucis, flexor digitorum brevis, flexor hallucis, quadratus plantae and abductor digiti minimi) and three extrinsic foot muscles (peronei, tibialis anterior and flexor digitorum longus) will be measured on images obtained using ultrasonography.
To obtain those images, the investigators will scan the muscles in a longitudinal view.
Measured: 8-week intervention period
Change in foot muscle cross-sectional area
The area of five intrinsic foot muscles (abductor hallucis, flexor digitorum brevis, flexor hallucis, quadratus plantae and abductor digiti minimi) and two extrinsic foot muscles (peronei and flexor digitorum longus) will be measured on images obtained using ultrasonography.
To obtain those images, the investigators will scan the muscles in a transversal view.
Measured: 8-week intervention period
Secondary outcomes (5)
Change in foot muscle strength
Foot muscle strength will be evaluated using a hand-held dynamometer, with participants hook lying. The investigators will both report the strength of the big toe and the strength of the other toes (as a whole).
Measured: 8-week intervention period
Change in foot Posture Index
The Foot Posture Index 6-item is a validated six-item criterion reference tool for quantifying standing foot posture and is used in a variety of clinical and research settings 33. It is a quick and reliable tool to quantify the degree to which a foot is pronated, neutral or supinated. The patient stands in a relaxed stance position with double limb support while the assessor evaluates a total of 6 items via observations and palpations.
Measured: 8-week intervention period
Change in navicular drop
The investigators will assess navicular drop as the difference in distance between the navicular tuberosity to the ground from sitting to double-limb stance.
Measured: 8-week intervention period
Change in the OSPRO-YF questionnaire
The OSPRO-YF questionnaire will be used to assess individual psychological scores, including: depressive symptoms, anxiety, anger, fear-avoidance beliefs, kinesiophobia, catastrophizing, self-efficacy, and pain acceptance 32. This questionnaire is designed to evaluate multiple psychological scores without burdening a person with completing each full instrument.OSPRO-YF summarizes 11 psychological questionnaires, quartile scores are used instead of cutoff scores for consistency and assessment of a wide range of outpatient orthopedic patients.
Measured: 8-week intervention period
Change in the FAOS questionnaire
The Foot and Ankle Outcome Score is a patient reported instrument useful for assessing changes in foot/ankle pathology over time with or without treatment. The score assesses pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and foot/ankle related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms.
Measured: 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jun 2023
- Primary completion1 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flatfoot, FlexibleStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective monocentric randomised controlled trial with an asymptomatic control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Haelewijn, KU Leuven
- Investigators
- Kevin Deschamps, PhD, Pod, Principal investigator, Musculoskeletal Rehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840965
- Sponsor's protocol ID
- B3222022001031
- Other IDs
- S67036
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2023
- Last updated
- 19 Feb 2025
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Foot Biomechanics and the Effect of Foot Core Exercises or Foot Orthotics in Symptomatic Flexible Flatfoot
- ClinicalTrials.gov ID
- NCT05840965
- Acronym / sponsor ID
- B3222022001031
- Conditions
- Flatfoot, Flexible
- Keywords
- Multi segment foot kinetics, Multi segment foot kinematics, Intrinsic foot muscles, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 3 May 2023 (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 overall goal of this study is to evaluate the effect of a foot strengthening program (focused on the intrinsic foot muscles) on ankle and foot joint kinematics and kinetics (rearfoot, midfoot, and forefoot) in patients with symptomatic flexible flat feet. The investigators will also evaluate the effect on intrinsic muscle morphology, foot strength, pain and other symptoms. The investigators will compare to the standard conservative therapy, which is foot orthotic therapy.
Detailed description
A common condition is "symptomatic flexible flat foot". This clinical entity affects 1 in 5 adults and is characterized by misalignment of the foot joints, resulting in a flat medial longitudinal foot arch. As a result, the foot's load-bearing capacity is reduced, leading to overuse injuries such as back pain, patellofemoral pain, or medial tibial stress syndrome.
The literature shows that people with flexible flat feet have disturbed foot and ankle kinematics during locomotor tasks. However, the current literature lacks insight into the kinetics of the foot joints (i.e., forces that cause joint movement) during both relatively simple tasks such as walking and running and more challenging tasks such as landing from a step. The recent development of multisegmental kinetic foot models allows for detailed information to be obtained regarding (mal)adaptive joint loading patterns in this population and address shortcomings in the current literature.
In recent years, the small intrinsic foot muscles (IFM) have received more attention in the treatment of foot and ankle-related overuse injuries, such as plantar fasciitis, medial tibial stress syndrome, and Achilles tendinopathy. According to the "foot core" paradigm, the primary role of the intrinsic foot muscles is to support the medial foot arch. They contribute to the absorptive and generative capacity of the medial foot arch and work together with the plantar aponeurosis, ligaments, and extrinsic foot muscles. It is known that their strength and volume are reduced in people with flat feet.
A randomized controlled trial will be planned in which participants with symptomatic flexible flatfeet will be allocated to either receiving foot core strengthening exercises or custom made foot orthotics therapy. An asymptomatic group with flexible flatfeet will serve as a control group and will not undergo any intervention.
Primary objective 1: To evaluate changes in foot joint kinetics and kinematics and intrinsic foot muscle size following a foot core strengthening program in participants with symptomatic flexible flatfoot and whether this is different to the control therapy.
Secondary objective 1: To evaluate changes in foot posture, foot muscle strength, psychological scores, pain and symptoms following a foot core strengthening program and whether these changes are different in comparison to the control therapy.
Secondary objective 2: To evaluate changes in foot joint kinematics and kinetics and intrinsic foot muscle size between participants with asymptomatic and symptomatic flexible flatfoot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective monocentric randomised controlled trial with an asymptomatic control group.
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic flexible flatfoot | No intervention | –This group undergoes no intervention. |
| Symptomatic flexible flatfoot: foot core strengthening | Experimental | Other: Foot muscle strengtheningThe investigators put together a specific training program emphasizing the neuromuscular recruitment of the plantar intrinsic foot muscles. This will be colloquially referred to as the "Foot Core Strengthening Program". The most recognized exercise of our program is the short foot exercise. However, as recently other exercises were validated by Gooding et al., we also included following exercises: toe spread out, first-toe extension and second- to fifth-toes extension. Simultaneously, neuromuscular electrical stimulation (NMES) will be provided, as 77% of healthy active people struggle performing contractions of the foot muscles. |
| Symptomatic flexible flatfoot: foot orthotics | Active comparator | Other: Foot orthoticsCustom-made foot orthotics are the current standard of care (SOC) therapy within this population. Patients choose their own health care provider to customize these orthotics. The sole is made of EVA material whose color and hardness is determined by the podiatrist or bandage maker. Digital scans or plaster of Paris cast will be taken of the participant's non-weightbearing foot (placed in a neutral or corrected position) by a certified pedorthist following the prescription of the orthopaedic surgeon. The geometry of the foot orthotic will encompass a total contact principle with respect to the medial arch. The orthotics will be manufactured using ethyl vinyl acetate (EVA) with a shore ranging between 45 and 60 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Adults between 18 and 65 years of age, able to run at a self- selected low speed.
- Physically active: min. 1h30 and max 6 h/week
- Foot Posture Index > 6 AND Navicular drop > 5 mm
- Informed consent (ICF) obtained
- cfr. supra
Key exclusion criteria (15 listed)
- < 18 years, > 65 years
- Any medical contraindication to physical exertion
- Systemic diseases
- Recent lower limb surgery (< 6 months)
- Lower limb osteosynthesis material
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 |
|---|---|---|
| Foot muscle strengtheningA specific training program emphasizing the neuromuscular recruitment of the plantar intrinsic foot muscles. This will be colloquially referred to as the "Foot Core Strengthening Program". The exercises are: short foot exercise, toe spread out, first toe extension, second to fifth toe extension. Simultaneously, neuromuscular electrical stimulation (NMES) will be provided, as 77% of healthy active people struggle performing contractions of the foot muscles. | Other | Symptomatic flexible flatfoot: foot core strengthening |
| Foot orthoticsCustom-made foot orthotics | Other | Symptomatic flexible flatfoot: foot orthotics |
Primary outcome
Change in lower limb joint angles (degrees)
Time frame: 8-week intervention period
Joint angles will be measured based on the position of passive markers placed on participants' anatomical landmarks all over the lower limbs. The position of those markers will be tracked by 10 infrared high-speed cameras that surround the walkway (sampled at 100 Hertz (Hz) - type T-10, 1 megapixel, captures 10-bit grayscale using 1120 * 896 pixels, Vicon Motion System Ltd, Oxford, Metrics, UK). The angular positions of the multiple joints that constitute the lower limb (hip, knee, ankle, chopart, lisfranc and metatarsophalangeal) will be assessed during walking, running, and single leg drop jump in the gait laboratory.
Change in lower limb joint angular velocities (degrees/second)
Time frame: 8-week intervention period
Joint angular velocities are also assessed based on reflexive markers placed on anatomical landmarks. This outcome evaluates the rate of change of a certain joint angle over time. Joint angular velocities will be assessed of the multiple joints that constitute the lower limb (hip, knee, ankle, chopart, lisfranc and metatarsophalangeal) during walking, running and a single leg drop jump in the gait laboratory.
Change in joint moments
Time frame: 8-week intervention period
Joint moments will be determined by coupling kinematic data (joint position and velocities) with plantar pressure data from a specially designed pressure plate (sampled at 200Hz, Footscan, dimension 0.5m x 0.4m, 4096 sensors, 2.8 sensors/cm², RsScan International, Olen, Belgium) embedded in the middle of the runway and placed on top of a force plate (sampled at 1000Hz, Advanced Mechanical Technology Inc., Watertown, MA, USA). Kinetic data will be assessed while walking, running and a single leg drop jump in the gait laboratory.
Change in foot muscle thickness
Time frame: 8-week intervention period
The thickness of five intrinsic foot muscles (abductor hallucis, flexor digitorum brevis, flexor hallucis, quadratus plantae and abductor digiti minimi) and three extrinsic foot muscles (peronei, tibialis anterior and flexor digitorum longus) will be measured on images obtained using ultrasonography. To obtain those images, the investigators will scan the muscles in a longitudinal view.
Change in foot muscle cross-sectional area
Time frame: 8-week intervention period
The area of five intrinsic foot muscles (abductor hallucis, flexor digitorum brevis, flexor hallucis, quadratus plantae and abductor digiti minimi) and two extrinsic foot muscles (peronei and flexor digitorum longus) will be measured on images obtained using ultrasonography. To obtain those images, the investigators will scan the muscles in a transversal view.
5 secondary outcomes
Change in foot muscle strength
Time frame: 8-week intervention period
Change in foot Posture Index
Time frame: 8-week intervention period
Change in navicular drop
Time frame: 8-week intervention period
Change in the OSPRO-YF questionnaire
Time frame: 8-week intervention period
Change in the FAOS questionnaire
Time frame: 8-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- 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.
Kevin Deschamps, PhD, Pod principal investigator
Musculoskeletal Rehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot muscle strengthening and Foot orthotics in people with Flatfoot, Flexible, run by KU Leuven at 1 site in Belgium.
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 17 inclusion and 15 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 19 Feb 2025. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in lower limb joint angles (degrees) (time frame: 8-week intervention period). The study lists 5 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 19 Feb 2025.