Plantar FasciitisPhase 4NCT01994759
Optimal Treatment of Plantar Fasciitis: Physical Training, Glucocorticoid Injections or a Combination Thereof.
A Phase 4 study testing Training, Glucocorticosteroid injection and Reduction in impact in people with Plantar Fasciitis, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether reduced load to patients with plantar fasciitis (reduced standing, walking, landing) together with either controlled heavy resistance training or glucocorticosteroid injection or a combination thereof is the best treatment. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Training, Glucocorticosteroid injection and Reduction in impact
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2013to 1 Dec 2016
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain at the medial attachment of fascia plantaris.
- First step pain in the morning
- Symptoms for at least 3 months.
- Age 20-65 years
- Ultrasound scanning at the first visit shows thickness of the fascia above 4 mm.
- Patient can read and understand danish
Who cannot join
- known arthritis, inflammatory bowl disease, psoriasis or clinical signs of any of these
- Leg ulcerations
- Longlasting oedema of the leg and foot
- Palpatory decreased puls in the foot
- Diabetes
- Reduced sensibility in the foot
Show all 12Show fewer
- Infections in the foot
- Daily use of pain killers
- Pregnancy or planning to become pregnant
- Earlier operations on the foot, that is judged to complicate training
- Patient assessed not to be able to participate in the training for other reasons
- Glucocorticosteroid injection to the diseased plantar fascia within the last 6 months.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Copenhagen, 2400
About this study
Official title: Optimal Treatment of Plantar Fasciitis: A Randomized Clinical Trial Using Physical Training, Glucocorticoid Injections or a Combination Thereof.
The purpose of this study is to determine whether reduced load to patients with plantar fasciitis (reduced standing, walking, landing) together with either controlled heavy resistance training or glucocorticosteroid injection or a combination thereof is the best treatment.
Read the detailed description
Plantar fasciitis (PF) is a frequently diagnosed condition, defined as pain at the medial tubercle of the calcaneus, and 10% of the population will at some points in their life experience this condition. Accumulated loading of the plantar fascia seems to relate to development of PF, as it is commonly seen in runners and those who are overweight, and number of daily steps or simply time of standing has been shown to be a predisposing factor for PF development.
Orthosis and glucocorticoid injections are 2 widely used treatments with proven effect. However treatment of overuse injury in other tendon/aponeurosis-like structures, has over the later years been dominated by an increasing documentation of a good curative effect of heavy controlled mechanical loading (eccentric strength exercises or heavy slow concentric strength training) upon tendinopathies in Achilles or patella tendon. However, no studies have looked at the influence of physical training (e.g. strength training) on the diseased plantar aponeurosis. Also no studies have looked at the effect of a combination of giving local glucocorticoid injection and training on this or other tendon overuse entities.
We hypothesize that heavy strength training will have a positive effect upon PF, and that a combination of training and glucocorticoid injections will have an additive effect upon this disease and be even more effective than each of the treatments alone. Glucocorticoid injection acting as the standard control treatment.
- Conditions
- Plantar Fasciitis
- Being tested
- Training, Glucocorticosteroid injection, Reduction in impact
- Keywords
- Plantar fasciitis, Treatment, Training, Glucocorticosteroid injection
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Also called Heavy slow resistance exercise, Eccentric training, stretching
Patients are instructed to carry out strengthening exercises for the fascia plantaris 3 days a week and stretching exercises every day. Four times in the first 2 months supervised training in groups is carried out with a physiotherapist supervising the exercises and instructing in progression and new exercises, and all participants are instructed to carry out a specific training program daily at home. The amount of training performed by each patient, is registered in a diary weekly
Glucocorticosteroid injectionDrug
Also called Methylprednisolone, Depo-medrol
Ultra sound guided injection af 1 ml og Glucocorticosteroid (methylprednisolone 40 mg) and 1 ml of lidocaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris.
Glucocorticosteroid injections are given every month until the aponeurosis thickness is less than 4 mm as determined by ultrasonography (max 3 injections).
Reduction in impactBehavioural
Also called Shock absorbtion
advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
| Study group | Role | What they receive |
|---|---|---|
| Training | Active comparator | strengthening and stretching exercises. Receives: Other: Training; Behavioral: Reduction in impact |
| Glucocorticosteroid injection | Active comparator | Injection of 40 mg methylprednisolone. Receives: Drug: Glucocorticosteroid injection; Behavioral: Reduction in impact |
| Training and Glucocorticosteroid injections | Active comparator | A combination treatment of the two above. Receives: Other: Training; Drug: Glucocorticosteroid injection; Behavioral: Reduction in impact |
What is being measured
The primary outcome is the main question the study is designed to answer.
100 mm VAS score pain at function. Average pain during everyday living.
Measured: 6 month
Foot Function Index
Foot function Index is a validated score for patients with plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230.
Measured: 6 month
Secondary outcomes (4)
100 mm VAS score for morning pain
Measured: at entry, 3 month (after intervention), 6 month, 12 month, 24 month
Ultrasound scanning thickness measure
measurement of the thickness of the thickest part of the fascia by B-mode Ultrasound scanning
Measured: at entry, 3 month (after intervention), 6 month, 12 month, 24 month
100 mm VAS score pain at function. Average pain during everyday living.
Measured: 3 months, 12 months, 24 months
Foot Function Index
Foot function Index is a validated score for patients with plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230.
Measured: 3 month, 12 month, 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study start1 Sep 2013
- Primary completion1 Jul 2015
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fonden for Faglig Udvikling af Speciallægepraksis, Denmark
- Responsible party
- Principal investigator, Finn Elkjær Johannsen, Bispebjerg Hospital
- Investigators
- Michael Kjær, Professor, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994759
- Sponsor's protocol ID
- H-2-2012-150-FJ
- Status last verified
- Jul 2018
- First submitted
- 10 Nov 2013
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Baldassin V, Gomes CR, Beraldo PS. Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Apr;90(4):701-6. doi: 10.1016/j.apmr.2008.11.002.
PubMed 19345789Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
PubMed 12917892Uden H, Boesch E, Kumar S. Plantar fasciitis - to jab or to support? A systematic review of the current best evidence. J Multidiscip Healthc. 2011;4:155-64. doi: 10.2147/JMDH.S20053. Epub 2011 May 24.
PubMed 21655342Vohra PK, Kincaid BR, Japour CJ, Sobel E. Ultrasonographic evaluation of plantar fascia bands. A retrospective study of 211 symptomatic feet. J Am Podiatr Med Assoc. 2002 Sep;92(8):444-9. doi: 10.7547/87507315-92-8-444.
PubMed 12237265Tobin L, Simonsen L, Bulow J. Real-time contrast-enhanced ultrasound determination of microvascular blood volume in abdominal subcutaneous adipose tissue in man. Evidence for adipose tissue capillary recruitment. Clin Physiol Funct Imaging. 2010 Nov;30(6):447-52. doi: 10.1111/j.1475-097X.2010.00964.x. Epub 2010 Aug 22.
PubMed 20731685Roos E, Engstrom M, Soderberg B. Foot orthoses for the treatment of plantar fasciitis. Foot Ankle Int. 2006 Aug;27(8):606-11. doi: 10.1177/107110070602700807.
PubMed 16919213Radford JA, Landorf KB, Buchbinder R, Cook C. Effectiveness of low-Dye taping for the short-term treatment of plantar heel pain: a randomised trial. BMC Musculoskelet Disord. 2006 Aug 9;7:64. doi: 10.1186/1471-2474-7-64.
PubMed 16895612Pfeffer G, Bacchetti P, Deland J, Lewis A, Anderson R, Davis W, Alvarez R, Brodsky J, Cooper P, Frey C, Herrick R, Myerson M, Sammarco J, Janecki C, Ross S, Bowman M, Smith R. Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis. Foot Ankle Int. 1999 Apr;20(4):214-21. doi: 10.1177/107110079902000402.
PubMed 10229276Kongsgaard M, Kovanen V, Aagaard P, Doessing S, Hansen P, Laursen AH, Kaldau NC, Kjaer M, Magnusson SP. Corticosteroid injections, eccentric decline squat training and heavy slow resistance training in patellar tendinopathy. Scand J Med Sci Sports. 2009 Dec;19(6):790-802. doi: 10.1111/j.1600-0838.2009.00949.x. Epub 2009 May 28.
PubMed 19793213Cheng JW, Tsai WC, Yu TY, Huang KY. Reproducibility of sonographic measurement of thickness and echogenicity of the plantar fascia. J Clin Ultrasound. 2012 Jan;40(1):14-9. doi: 10.1002/jcu.20903. Epub 2011 Nov 22.
PubMed 22109854Johannsen FE, Herzog RB, Malmgaard-Clausen NM, Hoegberget-Kalisz M, Magnusson SP, Kjaer M. Corticosteroid injection is the best treatment in plantar fasciitis if combined with controlled training. Knee Surg Sports Traumatol Arthrosc. 2019 Jan;27(1):5-12. doi: 10.1007/s00167-018-5234-6. Epub 2018 Nov 15.
PubMed 30443664
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Treatment of Plantar Fasciitis: A Randomized Clinical Trial Using Physical Training, Glucocorticoid Injections or a Combination Thereof.
- ClinicalTrials.gov ID
- NCT01994759
- Acronym / sponsor ID
- H-2-2012-150-FJ
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar fasciitis, Treatment, Training, Glucocorticosteroid injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Fonden for Faglig Udvikling af Speciallægepraksis, Denmark
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 26 Nov 2013 (estimated)
- 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 purpose of this study is to determine whether reduced load to patients with plantar fasciitis (reduced standing, walking, landing) together with either controlled heavy resistance training or glucocorticosteroid injection or a combination thereof is the best treatment.
Detailed description
Plantar fasciitis (PF) is a frequently diagnosed condition, defined as pain at the medial tubercle of the calcaneus, and 10% of the population will at some points in their life experience this condition. Accumulated loading of the plantar fascia seems to relate to development of PF, as it is commonly seen in runners and those who are overweight, and number of daily steps or simply time of standing has been shown to be a predisposing factor for PF development.
Orthosis and glucocorticoid injections are 2 widely used treatments with proven effect. However treatment of overuse injury in other tendon/aponeurosis-like structures, has over the later years been dominated by an increasing documentation of a good curative effect of heavy controlled mechanical loading (eccentric strength exercises or heavy slow concentric strength training) upon tendinopathies in Achilles or patella tendon. However, no studies have looked at the influence of physical training (e.g. strength training) on the diseased plantar aponeurosis. Also no studies have looked at the effect of a combination of giving local glucocorticoid injection and training on this or other tendon overuse entities.
We hypothesize that heavy strength training will have a positive effect upon PF, and that a combination of training and glucocorticoid injections will have an additive effect upon this disease and be even more effective than each of the treatments alone. Glucocorticoid injection acting as the standard control treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training | Active comparator | Other: Training, Behavioral: Reduction in impactstrengthening and stretching exercises. |
| Glucocorticosteroid injection | Active comparator | Drug: Glucocorticosteroid injection, Behavioral: Reduction in impactInjection of 40 mg methylprednisolone. |
| Training and Glucocorticosteroid injections | Active comparator | Other: Training, Drug: Glucocorticosteroid injection, Behavioral: Reduction in impactA combination treatment of the two above. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pain at the medial attachment of fascia plantaris.
- First step pain in the morning
- Symptoms for at least 3 months.
- Age 20-65 years
- Ultrasound scanning at the first visit shows thickness of the fascia above 4 mm.
Key exclusion criteria (12 listed)
- known arthritis, inflammatory bowl disease, psoriasis or clinical signs of any of these
- Leg ulcerations
- Longlasting oedema of the leg and foot
- Palpatory decreased puls in the foot
- Diabetes
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 |
|---|---|---|
| TrainingAlso: Heavy slow resistance exercise, Eccentric training, stretchingPatients are instructed to carry out strengthening exercises for the fascia plantaris 3 days a week and stretching exercises every day. Four times in the first 2 months supervised training in groups is carried out with a physiotherapist supervising the exercises and instructing in progression and new exercises, and all participants are instructed to carry out a specific training program daily at home. The amount of training performed by each patient, is registered in a diary weekly | Other | Training, Training and Glucocorticosteroid injections |
| Glucocorticosteroid injectionAlso: Methylprednisolone, Depo-medrolUltra sound guided injection af 1 ml og Glucocorticosteroid (methylprednisolone 40 mg) and 1 ml of lidocaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris. Glucocorticosteroid injections are given every month until the aponeurosis thickness is less than 4 mm as determined by ultrasonography (max 3 injections). | Drug | Glucocorticosteroid injection, Training and Glucocorticosteroid injections |
| Reduction in impactAlso: Shock absorbtionadvocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions. | Behavioural | Glucocorticosteroid injection, Training, Training and Glucocorticosteroid injections |
Primary outcome
100 mm VAS score pain at function. Average pain during everyday living.
Time frame: 6 month
Foot Function Index
Time frame: 6 month
Foot function Index is a validated score for patients with plantar fasciitis. It consists of 23 questions concerning pain, function and impact on daily life. Each question is answered on a box scale 0-10, giving a score range: 0-230.
4 secondary outcomes
100 mm VAS score for morning pain
Time frame: at entry, 3 month (after intervention), 6 month, 12 month, 24 month
Ultrasound scanning thickness measure
Time frame: at entry, 3 month (after intervention), 6 month, 12 month, 24 month
100 mm VAS score pain at function. Average pain during everyday living.
Time frame: 3 months, 12 months, 24 months
Foot Function Index
Time frame: 3 month, 12 month, 24 month
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 11 Jul 2018.
- Background: PubMed 19345789Baldassin V, Gomes CR, Beraldo PS. Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Apr;90(4):701-6. doi: 10.1016/j.apmr.2008.11.002.
- Background: PubMed 12917892Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database Syst Rev. 2003;(3):CD000416. doi: 10.1002/14651858.CD000416.
- Background: PubMed 21655342Uden H, Boesch E, Kumar S. Plantar fasciitis - to jab or to support? A systematic review of the current best evidence. J Multidiscip Healthc. 2011;4:155-64. doi: 10.2147/JMDH.S20053. Epub 2011 May 24.
- Background: PubMed 12237265Vohra PK, Kincaid BR, Japour CJ, Sobel E. Ultrasonographic evaluation of plantar fascia bands. A retrospective study of 211 symptomatic feet. J Am Podiatr Med Assoc. 2002 Sep;92(8):444-9. doi: 10.7547/87507315-92-8-444.
- Background: PubMed 20731685Tobin L, Simonsen L, Bulow J. Real-time contrast-enhanced ultrasound determination of microvascular blood volume in abdominal subcutaneous adipose tissue in man. Evidence for adipose tissue capillary recruitment. Clin Physiol Funct Imaging. 2010 Nov;30(6):447-52. doi: 10.1111/j.1475-097X.2010.00964.x. Epub 2010 Aug 22.
- Background: PubMed 16919213Roos E, Engstrom M, Soderberg B. Foot orthoses for the treatment of plantar fasciitis. Foot Ankle Int. 2006 Aug;27(8):606-11. doi: 10.1177/107110070602700807.
- Background: PubMed 16895612Radford JA, Landorf KB, Buchbinder R, Cook C. Effectiveness of low-Dye taping for the short-term treatment of plantar heel pain: a randomised trial. BMC Musculoskelet Disord. 2006 Aug 9;7:64. doi: 10.1186/1471-2474-7-64.
- Background: PubMed 10229276Pfeffer G, Bacchetti P, Deland J, Lewis A, Anderson R, Davis W, Alvarez R, Brodsky J, Cooper P, Frey C, Herrick R, Myerson M, Sammarco J, Janecki C, Ross S, Bowman M, Smith R. Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis. Foot Ankle Int. 1999 Apr;20(4):214-21. doi: 10.1177/107110079902000402.
- Background: PubMed 19793213Kongsgaard M, Kovanen V, Aagaard P, Doessing S, Hansen P, Laursen AH, Kaldau NC, Kjaer M, Magnusson SP. Corticosteroid injections, eccentric decline squat training and heavy slow resistance training in patellar tendinopathy. Scand J Med Sci Sports. 2009 Dec;19(6):790-802. doi: 10.1111/j.1600-0838.2009.00949.x. Epub 2009 May 28.
- Background: PubMed 22109854Cheng JW, Tsai WC, Yu TY, Huang KY. Reproducibility of sonographic measurement of thickness and echogenicity of the plantar fascia. J Clin Ultrasound. 2012 Jan;40(1):14-9. doi: 10.1002/jcu.20903. Epub 2011 Nov 22.
- Derived from this study: PubMed 30443664Johannsen FE, Herzog RB, Malmgaard-Clausen NM, Hoegberget-Kalisz M, Magnusson SP, Kjaer M. Corticosteroid injection is the best treatment in plantar fasciitis if combined with controlled training. Knee Surg Sports Traumatol Arthrosc. 2019 Jan;27(1):5-12. doi: 10.1007/s00167-018-5234-6. Epub 2018 Nov 15.
Related trials for Plantar Fasciitis
Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Active, not recruiting
Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
Plantar Fascitis
Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic
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.
Michael Kjær, Professor study chair
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Training, Glucocorticosteroid injection and Reduction in impact in people with Plantar Fasciitis, run by Bispebjerg Hospital at 1 site in Denmark.
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 6 inclusion and 12 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 11 Jul 2018. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
100 mm VAS score pain at function. Average pain during everyday living. (time frame: 6 month). 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 NCT01994759, which also lists 11 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 11 Jul 2018.