Sports Physical TherapyNCT06479525

Comparative Effects of Big Toe Flexor and Calf Strengthening Exercises on Medial Arch in Athletes With Flat Foot

A study testing Big Toe Flexor Strengthening Exercises and Calf Strengthening Exercises in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Sports Physical Therapy
What is being tested?: Big Toe Flexor Strengthening Exercises and Calf Strengthening Exercises
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 sitePakistan
Study dates: 23 Nov 2023to 30 May 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 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age between 18 and 30 years' old
Both male and female
Athletes involved in sports with more than one year
Athletes with asymptomatic flexible flatfoot (NDT > 10mm) (5)

Who cannot join

Congenital flatfoot
Athletes using foot orthoses
Any lower limb muscle injury or trauma in the past 6 months
Had undergone lower limb surgery
Had lower extremity deformities: pes cavus, pes equinus, hallux valgus with greater angle than 15°, or clubfoot.(5)
Had a sign of neurological deficit over the lower extremities.
Female subjects if they were pregnant.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Pakistan Sports Board
Lahore, Punjab Province, 5400

Other trials in Pakistan

About this study

Flexible flatfoot is common in young adults. One of its causes is the failure of dynamic stabilizers, which play an important role in the medial longitudinal arch support, and their appropriate function is necessary for the integrity of the lower extremity and the spine. The metatarsal phalangeal joint (MPJ) and its crossing toe flexor muscles (TFM) represent the link between the large energy generating leg extensor muscles and the ground. Asymptomatic flat foot deformity is associated with gastrocnemius muscle tightness and a higher prevalence of gastrocnemius and soleus tightness was found in female subjects compared with males.

The study will be a randomized clinical trial. The study will be conducted in Pakistan Sports Board (PSB) Lahore. The sample size will be calculated by convenience sampling technique. The inclusion criteria will be participants of age between eighteen and thirty years old. Both male and female participants will be included. Athletes involved in sports more than one year and with asymptomatic flexible flatfeet (NDT > 10mm) will be included. Navicular drop test, Foot function index questionnaire, arch height index, toe/hip dynamometer and vertical jump test will be the tools used for assessment and evaluation. Participants who meet the inclusion criteria will be divided into two groups. Baseline measures and eight-week assessment of navicular drop test and arch height index will be taken. Strength of toe flexors will be evaluated with toe dynamometer. Participants who will meet the inclusion criteria will be provided with ethical consent forms and after baseline assessments, exercise program will be guided. Group A will perform big toe flexor strengthening exercises in addition to the sports plan they already follow. Group B will be assigned with calf strengthening exercises in addition to the plan they are following. Eight-week intervention program will be provided that will include warm up, therapeutic exercises including toe raises, towel curls and therapeutic band exercises, and then cool down period that includes stretching exercises.

Read the detailed description

The main objective of the study is to apply big toe flexor and calf muscles strengthening exercises and to compare the results to identify their influence on medial longitudinal arch in flexible flat foot athletes.

Conditions: Sports Physical Therapy
Being tested: Big Toe Flexor Strengthening Exercises, Calf Strengthening Exercises
Keywords: Dynamometer, Calf Muscle, Flatfoot, Muscle Strength, Big Toe
Medical subject headings: Flatfoot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Big Toe Flexor Strengthening ExercisesOther
16 participants will be in experimental group A giving them Big Toe Flexor strengthening exercise protocol along with the sports training plan for eight weeks measuring all values before giving them protocol and after protocol.
Calf Strengthening ExercisesOther
16 participants will be in experimental group B giving them calf strengthening exercises including towel curls and thera band exercises along with the sports training plan for eight weeks measuring all values before giving them protocol and after protocol.

Study groups in NCT06479525
Study group	Role	What they receive
Group A	Experimental	16 participants will be in experimental group giving them Big Toe flexor strengthening exercises protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol. Receives: Other: Big Toe Flexor Strengthening Exercises
Group B	Experimental	16 participants will be in experimental group giving them calf strengthening exercises protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol. Receives: Other: Calf Strengthening Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

Navicular Drop Test
Navicular Drop Test is done by asking the subjects to sit on a chair with their knee and ankle in 90 ͦ and the navicular tubercle of their foot was palpated and marked on its greatest prominence. The examiner then determined the neutral position of the subtalar joint and this position was used for measurement. Then, a card was used to measure and mark the vertical height of the navicular bone in the non-weight bearing position. The height of the navicular bone was measured again in a full weight bearing position and marked on the same card. The difference between the initial and the second heights of this bone was labeled as the "Navicular Drop" index. (7)
Measured: 8 weeks
Foot Function Index
A Revised - Foot Function Index - Short form questionnaire consisting of 34 items will be used. This questionnaire includes five subscales: pain, stiffness, difficulty, activity limitation and social issues. The cumulative score of all the subscales will be added and divided by five. The higher the score, the more limitation/pain/disability is present. (15)
Measured: 8 weeks
Arch Height Index
Arch height index is measured by dividing the dorsum height at 50%-foot length by the truncated foot length expressed. The truncated foot length is a distance between center of the first metatarsophalangeal joint to posterior calcaneus. The measurement can be done both in relaxed standing (weight bearing) and sitting (non-weight bearing) conditions. The good intra-rater reliability study in children aged six to 12 years (ICCs ranged from 0.84 to 0.87). (5)
Measured: 8 weeks
Vertical Jump Test
The athlete stands side on to a wall and reaches up with the hand closest to the wall. Keeping the feet flat on the ground, the point of the fingertips (covered with chalk) is marked or recorded. This is called the standing reach height. The athlete then stands away from the wall, and leaps vertically as high as possible using both arms and legs to assist in projecting the body upwards. The jumping technique can or cannot use a countermovement. Attempt to touch the wall at the highest point of the jump. The difference in distance between the standing reach height and the jump height is the score. The best of three attempts is recorded. (1)
Measured: 8 weeks
Hip and Toe Dynamometer
Athletes will place their feet on the ground prepared in accordance with the big toe and adjusted their big toes according to the location of the pinch meter. During the measurement, athletes will be asked to perform big toe flexion by applying maximum force with their big toe. Strength measurements were made on the athletes in the sitting position without any support.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Nov 202330 May 2024

First posted28 Jun 2024
Study start23 Nov 2023
Primary completion30 Apr 2024
Study completion30 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
More trials run by Riphah International UniversityThe 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
Masking: Single blind
Who is masked: Participant
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06479525
Sponsor's protocol ID: REC/RCR & AHS/23/0488 Mannan
Status last verified: Jun 2024
First submitted: 24 Jun 2024
Last updated: 28 Jun 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hashimoto T, Sakuraba K. Strength training for the intrinsic flexor muscles of the foot: effects on muscle strength, the foot arch, and dynamic parameters before and after the training. J Phys Ther Sci. 2014 Mar;26(3):373-6. doi: 10.1589/jpts.26.373. Epub 2014 Mar 25.
PubMed 24707086
Lee MS, Vanore JV, Thomas JL, Catanzariti AR, Kogler G, Kravitz SR, Miller SJ, Gassen SC; Clinical Practice Guideline Adult Flatfoot Panel. Diagnosis and treatment of adult flatfoot. J Foot Ankle Surg. 2005 Mar-Apr;44(2):78-113. doi: 10.1053/j.jfas.2004.12.001. No abstract available.
PubMed 15768358
Harutaichun P, Vongsirinavarat M, Pakpakorn P, Sathianpantarit P, Richards J. Can orthotic wedges change the lower-extremity and multi-segment foot kinematics during gait in people with plantar fasciitis? Gait Posture. 2022 Sep;97:174-183. doi: 10.1016/j.gaitpost.2022.07.259. Epub 2022 Aug 2.
PubMed 35964335
Desmyttere G, Hajizadeh M, Bleau J, Begon M. Effect of foot orthosis design on lower limb joint kinematics and kinetics during walking in flexible pes planovalgus: A systematic review and meta-analysis. Clin Biomech (Bristol). 2018 Nov;59:117-129. doi: 10.1016/j.clinbiomech.2018.09.018. Epub 2018 Sep 13.
PubMed 30227277
Engkananuwat P, Kanlayanaphotporn R. Gluteus medius muscle strengthening exercise effects on medial longitudinal arch height in individuals with flexible flatfoot: a randomized controlled trial. J Exerc Rehabil. 2023 Feb 23;19(1):57-66. doi: 10.12965/jer.2244572.286. eCollection 2023 Feb.
PubMed 36910682
DiGiovanni CW, Langer P. The role of isolated gastrocnemius and combined Achilles contractures in the flatfoot. Foot Ankle Clin. 2007 Jun;12(2):363-79, viii. doi: 10.1016/j.fcl.2007.03.005.
PubMed 17561207
Saeki J, Tojima M, Torii S. Clarification of functional differences between the hallux and lesser toes during the single leg stance: immediate effects of conditioning contraction of the toe plantar flexion muscles. J Phys Ther Sci. 2015 Sep;27(9):2701-4. doi: 10.1589/jpts.27.2701. Epub 2015 Sep 30.
PubMed 26504272
Jung DY, Kim MH, Koh EK, Kwon OY, Cynn HS, Lee WH. A comparison in the muscle activity of the abductor hallucis and the medial longitudinal arch angle during toe curl and short foot exercises. Phys Ther Sport. 2011 Feb;12(1):30-5. doi: 10.1016/j.ptsp.2010.08.001. Epub 2010 Sep 15.
PubMed 21256447
Yamauchi J, Koyama K. Importance of toe flexor strength in vertical jump performance. J Biomech. 2020 May 7;104:109719. doi: 10.1016/j.jbiomech.2020.109719. Epub 2020 Feb 26.
PubMed 32173032
Tahmasbi A, Shadmehr A, Attarbashi Moghadam B, Fereydounnia S. Does Kinesio taping of tibialis posterior or peroneus longus have an immediate effect on improving foot posture, dynamic balance, and biomechanical variables in young women with flexible flatfoot? Foot (Edinb). 2023 Sep;56:102032. doi: 10.1016/j.foot.2023.102032. Epub 2023 Mar 31.
PubMed 37019042
Aboelnasr EA, El-Talawy HA, Abdelazim FH, Hegazy FA. Sensitivity and specificity of normalized truncated navicular height in assessment of static foot posture in children aged 6-12 years. Hong Kong Physiother J. 2019 Jun;39(1):15-23. doi: 10.1142/S1013702519500021. Epub 2018 Oct 12.
PubMed 31156314
Budiman-Mak E, Conrad KJ, Roach KE. The Foot Function Index: a measure of foot pain and disability. J Clin Epidemiol. 1991;44(6):561-70. doi: 10.1016/0895-4356(91)90220-4.
PubMed 2037861
Mickle KJ, Caputi P, Potter JM, Steele JR. Efficacy of a progressive resistance exercise program to increase toe flexor strength in older people. Clin Biomech (Bristol). 2016 Dec;40:14-19. doi: 10.1016/j.clinbiomech.2016.10.005. Epub 2016 Oct 7.
PubMed 27780109
Moore J, Tafti D. Pes Planus. 2026 Feb 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK430802/
PubMed 28613553
Toullec E. Adult flatfoot. Orthop Traumatol Surg Res. 2015 Feb;101(1 Suppl):S11-7. doi: 10.1016/j.otsr.2014.07.030. Epub 2015 Jan 13.
PubMed 25595429

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effects of Big Toe Flexor and Calf Strengthening Exercises on Medial Arch in Athletes With Flat Foot
ClinicalTrials.gov ID: NCT06479525
Acronym / sponsor ID: REC/RCR & AHS/23/0488 Mannan
Conditions: Sports Physical Therapy
Keywords: Dynamometer, Calf Muscle, Flatfoot, Muscle Strength, Big Toe
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Riphah International UniversityUniversity, hospital or other
Study start: 23 Nov 2023 (actual)
Primary completion: 30 Apr 2024 (actual)
Study completion: 30 May 2024 (actual)
First posted: 28 Jun 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Other: Big Toe Flexor Strengthening Exercises16 participants will be in experimental group giving them Big Toe flexor strengthening exercises protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol.
Group B	Experimental	Other: Calf Strengthening Exercises16 participants will be in experimental group giving them calf strengthening exercises protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol.

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age between 18 and 30 years' old
Both male and female
Athletes involved in sports with more than one year
Athletes with asymptomatic flexible flatfoot (NDT > 10mm) (5)

Key exclusion criteria (7 listed)

Congenital flatfoot
Athletes using foot orthoses
Any lower limb muscle injury or trauma in the past 6 months
Had undergone lower limb surgery
Had lower extremity deformities: pes cavus, pes equinus, hallux valgus with greater angle than 15°, or clubfoot.(5)

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
Big Toe Flexor Strengthening Exercises16 participants will be in experimental group A giving them Big Toe Flexor strengthening exercise protocol along with the sports training plan for eight weeks measuring all values before giving them protocol and after protocol.	Other	Group A
Calf Strengthening Exercises16 participants will be in experimental group B giving them calf strengthening exercises including towel curls and thera band exercises along with the sports training plan for eight weeks measuring all values before giving them protocol and after protocol.	Other	Group B

Primary outcome

Navicular Drop Test
Time frame: 8 weeks
Navicular Drop Test is done by asking the subjects to sit on a chair with their knee and ankle in 90 ͦ and the navicular tubercle of their foot was palpated and marked on its greatest prominence. The examiner then determined the neutral position of the subtalar joint and this position was used for measurement. Then, a card was used to measure and mark the vertical height of the navicular bone in the non-weight bearing position. The height of the navicular bone was measured again in a full weight bearing position and marked on the same card. The difference between the initial and the second heights of this bone was labeled as the "Navicular Drop" index. (7)
Foot Function Index
Time frame: 8 weeks
A Revised - Foot Function Index - Short form questionnaire consisting of 34 items will be used. This questionnaire includes five subscales: pain, stiffness, difficulty, activity limitation and social issues. The cumulative score of all the subscales will be added and divided by five. The higher the score, the more limitation/pain/disability is present. (15)
Arch Height Index
Time frame: 8 weeks
Arch height index is measured by dividing the dorsum height at 50%-foot length by the truncated foot length expressed. The truncated foot length is a distance between center of the first metatarsophalangeal joint to posterior calcaneus. The measurement can be done both in relaxed standing (weight bearing) and sitting (non-weight bearing) conditions. The good intra-rater reliability study in children aged six to 12 years (ICCs ranged from 0.84 to 0.87). (5)
Vertical Jump Test
Time frame: 8 weeks
The athlete stands side on to a wall and reaches up with the hand closest to the wall. Keeping the feet flat on the ground, the point of the fingertips (covered with chalk) is marked or recorded. This is called the standing reach height. The athlete then stands away from the wall, and leaps vertically as high as possible using both arms and legs to assist in projecting the body upwards. The jumping technique can or cannot use a countermovement. Attempt to touch the wall at the highest point of the jump. The difference in distance between the standing reach height and the jump height is the score. The best of three attempts is recorded. (1)
Hip and Toe Dynamometer
Time frame: 8 weeks
Athletes will place their feet on the ground prepared in accordance with the big toe and adjusted their big toes according to the location of the pinch meter. During the measurement, athletes will be asked to perform big toe flexion by applying maximum force with their big toe. Strength measurements were made on the athletes in the sitting position without any support.

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 28 Jun 2024.
Background: PubMed 24707086Hashimoto T, Sakuraba K. Strength training for the intrinsic flexor muscles of the foot: effects on muscle strength, the foot arch, and dynamic parameters before and after the training. J Phys Ther Sci. 2014 Mar;26(3):373-6. doi: 10.1589/jpts.26.373. Epub 2014 Mar 25.
Background: PubMed 15768358Lee MS, Vanore JV, Thomas JL, Catanzariti AR, Kogler G, Kravitz SR, Miller SJ, Gassen SC; Clinical Practice Guideline Adult Flatfoot Panel. Diagnosis and treatment of adult flatfoot. J Foot Ankle Surg. 2005 Mar-Apr;44(2):78-113. doi: 10.1053/j.jfas.2004.12.001. No abstract available.
Background: PubMed 35964335Harutaichun P, Vongsirinavarat M, Pakpakorn P, Sathianpantarit P, Richards J. Can orthotic wedges change the lower-extremity and multi-segment foot kinematics during gait in people with plantar fasciitis? Gait Posture. 2022 Sep;97:174-183. doi: 10.1016/j.gaitpost.2022.07.259. Epub 2022 Aug 2.
Background: PubMed 30227277Desmyttere G, Hajizadeh M, Bleau J, Begon M. Effect of foot orthosis design on lower limb joint kinematics and kinetics during walking in flexible pes planovalgus: A systematic review and meta-analysis. Clin Biomech (Bristol). 2018 Nov;59:117-129. doi: 10.1016/j.clinbiomech.2018.09.018. Epub 2018 Sep 13.
Background: PubMed 36910682Engkananuwat P, Kanlayanaphotporn R. Gluteus medius muscle strengthening exercise effects on medial longitudinal arch height in individuals with flexible flatfoot: a randomized controlled trial. J Exerc Rehabil. 2023 Feb 23;19(1):57-66. doi: 10.12965/jer.2244572.286. eCollection 2023 Feb.
Background: PubMed 17561207DiGiovanni CW, Langer P. The role of isolated gastrocnemius and combined Achilles contractures in the flatfoot. Foot Ankle Clin. 2007 Jun;12(2):363-79, viii. doi: 10.1016/j.fcl.2007.03.005.
Background: PubMed 26504272Saeki J, Tojima M, Torii S. Clarification of functional differences between the hallux and lesser toes during the single leg stance: immediate effects of conditioning contraction of the toe plantar flexion muscles. J Phys Ther Sci. 2015 Sep;27(9):2701-4. doi: 10.1589/jpts.27.2701. Epub 2015 Sep 30.
Background: PubMed 21256447Jung DY, Kim MH, Koh EK, Kwon OY, Cynn HS, Lee WH. A comparison in the muscle activity of the abductor hallucis and the medial longitudinal arch angle during toe curl and short foot exercises. Phys Ther Sport. 2011 Feb;12(1):30-5. doi: 10.1016/j.ptsp.2010.08.001. Epub 2010 Sep 15.
Background: PubMed 32173032Yamauchi J, Koyama K. Importance of toe flexor strength in vertical jump performance. J Biomech. 2020 May 7;104:109719. doi: 10.1016/j.jbiomech.2020.109719. Epub 2020 Feb 26.
Background: PubMed 37019042Tahmasbi A, Shadmehr A, Attarbashi Moghadam B, Fereydounnia S. Does Kinesio taping of tibialis posterior or peroneus longus have an immediate effect on improving foot posture, dynamic balance, and biomechanical variables in young women with flexible flatfoot? Foot (Edinb). 2023 Sep;56:102032. doi: 10.1016/j.foot.2023.102032. Epub 2023 Mar 31.
Background: PubMed 31156314Aboelnasr EA, El-Talawy HA, Abdelazim FH, Hegazy FA. Sensitivity and specificity of normalized truncated navicular height in assessment of static foot posture in children aged 6-12 years. Hong Kong Physiother J. 2019 Jun;39(1):15-23. doi: 10.1142/S1013702519500021. Epub 2018 Oct 12.
Background: PubMed 2037861Budiman-Mak E, Conrad KJ, Roach KE. The Foot Function Index: a measure of foot pain and disability. J Clin Epidemiol. 1991;44(6):561-70. doi: 10.1016/0895-4356(91)90220-4.
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.

Aamir Gul Memon, MS principal investigator

Riphah International University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Big Toe Flexor Strengthening Exercises and Calf Strengthening Exercises in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.

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: finished, as of the sponsor's last update on 28 Jun 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 Pakistan. 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?

Navicular Drop Test (time frame: 8 weeks). 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?

On the ClinicalTrials.gov record for NCT06479525, which also lists 16 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 28 Jun 2024.