Osteo Arthritis KneeNCT07141316
Effects of Blood Flow Restriction Combined With Electrostimulation After Knee Arthroplasty
A study testing Blood flow restriction combined with electrostimulation. in people with Osteo Arthritis Knee, run by University of Pavia at 1 site in Italy.
Trial summary
The goal of this clinical trial is to learn whether blood flow restriction (BFR) combined with electrostimulation (ES) can improve the postoperative course of patients undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Blood flow restriction combined with electrostimulation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jul 2025to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective knee arthroplasty surgery
Who cannot join
- obesity (body mass index equal to or greater than 30 Kg/m2);
- concomitant orthopaedic or neurological pathologies (other than the pathology for which arthroprosthesis has been indicated) that modify walking capacity;
- pathologies that modify the balance (neurological and/or vestibular);
- contraindications to the use of medical equipment used in the practice;
- inability to understand and sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Blood Flow Restriction Combined With Electrostimulation After Knee Arthroplasty: Randomized Controlled Trial
The goal of this clinical trial is to learn whether blood flow restriction (BFR) combined with electrostimulation (ES) can improve the postoperative course of patients undergoing total knee arthroplasty. The main questions it aims to answer are:
Immediately after surgery, do BFR combined with ES increase quadriceps strength? Do they also improve the functional abilities of patients? Researchers will compare BFR combined with ES to ES alone, to see if there are differences.
Participants will carry out a daily session of BFR+ ES or ES alone for six working days after surgery
Read the detailed description
Blood flow restriction (BFR) is an innovative treatment technique that involves the application of controlled pressure, through a special sleeve, to partially limit arterial flow and completely prevent venous outflow in the active muscles during exercise.
This approach is based on a hemodynamic modulation that induces a hypoxic environment at the muscle level, favoring the activation of metabolic processes and cellular mechanisms responsible for positive adaptations, such as the increase in protein synthesis, the promotion of muscle hypertrophy, aerobic capacity and the management of pain perception.
In rehabilitation, blood flow restriction treatment has been recognized as an effective strategy to promote functional recovery, offering benefits comparable to those of traditional treatment with high loads. This methodology is particularly useful in contexts where the use of high loads is contraindicated, such as in patients with orthopaedic limitations, with muscle weakness or undergoing surgery because it induces significant muscle adaptation even with low loads. The latest evidence indicates that reduced Limb occlusion pressures (LOP) (40% of blood pressure) achieve similar benefits to high pressures (80%) and are appreciated by patients. In the middle-aged and elderly population, the efficacy of BFR has been widely demonstrated but the studies that have investigated its effects on patients undergoing Knee Arthroplasty (KA) are few, of poor quality and carried out in the advanced rehabilitation phase. Patients undergoing KA at the "Città di Pavia" University Hospital, from the first post-operative day, perform a standard rehabilitation program including: passive mobilization, assisted active exercises, indirect electrostimulation and gait re-education. Although the results are positive, in the first few days, there are cases in which problems such as loss of muscle strength and functionality and persistence of pain occur; these sequelae are in agreement with the most recent literature.
Based on the rationale, the study aims to evaluate, in a group of patients undergoing KA, the short-term effects of electrostimulation combined with BFR and compare them with those of a group that will carry out the standard treatment. The treatment steps will be as follows:
- positioning of electrodes for electrostimulation on the quadriceps of the operated limb; II. application of the pneumatic band to the root of the thigh and LOP setting; III. programmazione dei parametri della BFR (LOP, 50%) (Occlusion time, 6 periods of 4 minutes of occlusion and 1 minutes of rest); IV. simultaneous start-up of the two devices.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Blood flow restriction combined with electrostimulation.
- Keywords
- Blood Flow Restriction, Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction combined with electrostimulation.Device
Participants will perform 30 minutes of blood flow restriction once a day during electrostimulation of the quadriceps of the operated limb.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction and Electrostimulation (GEL) | Experimental | For six working days, starting from the third day after surgery, he will perform 30 minutes of blood flow restriction once a day during electrostimulation of the quadriceps of the operated limb. Receives: Device: Blood flow restriction combined with electrostimulation. |
| Electrostimulation alone (GST) | No intervention | For six working days, starting from the third day after surgery, he will perform 30 minutes of electrostimulation of the quadriceps of the operated limb once a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum quadriceps strength of the operated limb
Maximum quadriceps strength, measured with a dynamometer and expressed in kilograms
Measured: From the second to the tenth day post surgery.
Secondary outcomes (3)
Functional Capacities
Timed Up and Go test ( seconds) and the 30 Seconds Chair Stand test (number of repetitions) will performed.
Measured: From the second to the tenth day post surgery.
Functional Strength
30 Seconds Chair Stand test (number of repetitions)
Measured: From the second to the tenth day post surgery.
Walking autonomy
20 meters walking test (seconds)
Measured: From the second to the tenth day post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start10 Jul 2025
- Primary completion10 Apr 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- luca Marin, PhD, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141316
- Sponsor's protocol ID
- BFR01
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On justified request and in anonymised form.
Publications
Praetorius A. [Blood flow restriction training (BFRT) in patients before and after total knee arthroplasty]. Orthopadie (Heidelb). 2024 Nov;53(11):853-857. doi: 10.1007/s00132-024-04543-1. Epub 2024 Aug 9. German.
PubMed 39120683Conference Proceedings for the 10th Annual Meeting of Arthroplasty Society in Asia (ASIA), 26th Annual Meeting of the Thai Hip and Knee Society (THKS), and the 16th Annual Meeting of the ASEAN Arthroplasty Association (AAA). Arthroplasty. 2024 Dec 20;6(Suppl 1):62. doi: 10.1186/s42836-024-00286-8. No abstract available.
PubMed 39702276Wengle L, Migliorini F, Leroux T, Chahal J, Theodoropoulos J, Betsch M. The Effects of Blood Flow Restriction in Patients Undergoing Knee Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Aug;50(10):2824-2833. doi: 10.1177/03635465211027296. Epub 2021 Aug 18.
PubMed 34406084De Renty C, Forelli F, Mazeas J, Kakavas G, Hewett TE, Korakakis V. Knee Loading With Blood Flow Restriction Can Enhance Recovery After Total Knee Arthroplasty. Cureus. 2023 Apr 20;15(4):e37895. doi: 10.7759/cureus.37895. eCollection 2023 Apr.
PubMed 37214015Zhang T, Wang X, Wang J. Effect of blood flow restriction combined with low-intensity training on the lower limbs muscle strength and function in older adults: A meta-analysis. Exp Gerontol. 2022 Jul;164:111827. doi: 10.1016/j.exger.2022.111827. Epub 2022 May 1.
PubMed 35508279Chang H, Yao M, Chen B, Qi Y, Zhang J. Effects of Blood Flow Restriction Combined with Low-Intensity Resistance Training on Lower-Limb Muscle Strength and Mass in Post-Middle-Aged Adults: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Nov 25;19(23):15691. doi: 10.3390/ijerph192315691.
PubMed 36497769Das A, Paton B. Is There a Minimum Effective Dose for Vascular Occlusion During Blood Flow Restriction Training? Front Physiol. 2022 Apr 8;13:838115. doi: 10.3389/fphys.2022.838115. eCollection 2022.
PubMed 35464074Freitas EDS, Miller RM, Heishman AD, Ferreira-Junior JB, Araujo JP, Bemben MG. Acute Physiological Responses to Resistance Exercise With Continuous Versus Intermittent Blood Flow Restriction: A Randomized Controlled Trial. Front Physiol. 2020 Mar 17;11:132. doi: 10.3389/fphys.2020.00132. eCollection 2020.
PubMed 32256374Barber-Westin S, Noyes FR. Blood Flow-Restricted Training for Lower Extremity Muscle Weakness due to Knee Pathology: A Systematic Review. Sports Health. 2019 Jan/Feb;11(1):69-83. doi: 10.1177/1941738118811337. Epub 2018 Nov 26.
PubMed 30475660Loenneke JP, Abe T, Wilson JM, Thiebaud RS, Fahs CA, Rossow LM, Bemben MG. Blood flow restriction: an evidence based progressive model (Review). Acta Physiol Hung. 2012 Sep;99(3):235-50. doi: 10.1556/APhysiol.99.2012.3.1.
PubMed 22982712Bielitzki R, Behrendt T, Behrens M, Schega L. Time to Save Time: Beneficial Effects of Blood Flow Restriction Training and the Need to Quantify the Time Potentially Saved by Its Application During Musculoskeletal Rehabilitation. Phys Ther. 2021 Oct 1;101(10):pzab172. doi: 10.1093/ptj/pzab172.
PubMed 34228788Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1.
PubMed 25430600A. K. Sandilya, D. Kashyap, A. Arunmozhi, M. Wadhwa, e V. Verma, "The importance of Blood Flow Restriction Training (BFRT) in Physiotherapy: A Review of Literature", J. Reatt. Ther. Dev. Divers., ago. 2023, doi: 10.53555/jrtdd.v6i8s.2643.
Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
PubMed 33560326Xia B, Di Chen, Zhang J, Hu S, Jin H, Tong P. Osteoarthritis pathogenesis: a review of molecular mechanisms. Calcif Tissue Int. 2014 Dec;95(6):495-505. doi: 10.1007/s00223-014-9917-9. Epub 2014 Oct 14.
PubMed 25311420
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Combined With Electrostimulation After Knee Arthroplasty: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07141316
- Acronym / sponsor ID
- BFR01
- Conditions
- Osteo Arthritis Knee
- Keywords
- Blood Flow Restriction, Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 26 Aug 2025 (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 goal of this clinical trial is to learn whether blood flow restriction (BFR) combined with electrostimulation (ES) can improve the postoperative course of patients undergoing total knee arthroplasty. The main questions it aims to answer are:
Immediately after surgery, do BFR combined with ES increase quadriceps strength? Do they also improve the functional abilities of patients? Researchers will compare BFR combined with ES to ES alone, to see if there are differences.
Participants will carry out a daily session of BFR+ ES or ES alone for six working days after surgery
Detailed description
Blood flow restriction (BFR) is an innovative treatment technique that involves the application of controlled pressure, through a special sleeve, to partially limit arterial flow and completely prevent venous outflow in the active muscles during exercise.
This approach is based on a hemodynamic modulation that induces a hypoxic environment at the muscle level, favoring the activation of metabolic processes and cellular mechanisms responsible for positive adaptations, such as the increase in protein synthesis, the promotion of muscle hypertrophy, aerobic capacity and the management of pain perception.
In rehabilitation, blood flow restriction treatment has been recognized as an effective strategy to promote functional recovery, offering benefits comparable to those of traditional treatment with high loads. This methodology is particularly useful in contexts where the use of high loads is contraindicated, such as in patients with orthopaedic limitations, with muscle weakness or undergoing surgery because it induces significant muscle adaptation even with low loads. The latest evidence indicates that reduced Limb occlusion pressures (LOP) (40% of blood pressure) achieve similar benefits to high pressures (80%) and are appreciated by patients. In the middle-aged and elderly population, the efficacy of BFR has been widely demonstrated but the studies that have investigated its effects on patients undergoing Knee Arthroplasty (KA) are few, of poor quality and carried out in the advanced rehabilitation phase. Patients undergoing KA at the "Città di Pavia" University Hospital, from the first post-operative day, perform a standard rehabilitation program including: passive mobilization, assisted active exercises, indirect electrostimulation and gait re-education. Although the results are positive, in the first few days, there are cases in which problems such as loss of muscle strength and functionality and persistence of pain occur; these sequelae are in agreement with the most recent literature.
Based on the rationale, the study aims to evaluate, in a group of patients undergoing KA, the short-term effects of electrostimulation combined with BFR and compare them with those of a group that will carry out the standard treatment. The treatment steps will be as follows:
- positioning of electrodes for electrostimulation on the quadriceps of the operated limb; II. application of the pneumatic band to the root of the thigh and LOP setting; III. programmazione dei parametri della BFR (LOP, 50%) (Occlusion time, 6 periods of 4 minutes of occlusion and 1 minutes of rest); IV. simultaneous start-up of the two devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction and Electrostimulation (GEL) | Experimental | Device: Blood flow restriction combined with electrostimulation.For six working days, starting from the third day after surgery, he will perform 30 minutes of blood flow restriction once a day during electrostimulation of the quadriceps of the operated limb. |
| Electrostimulation alone (GST) | No intervention | –For six working days, starting from the third day after surgery, he will perform 30 minutes of electrostimulation of the quadriceps of the operated limb once a day |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective knee arthroplasty surgery
Key exclusion criteria (5 listed)
- obesity (body mass index equal to or greater than 30 Kg/m2);
- concomitant orthopaedic or neurological pathologies (other than the pathology for which arthroprosthesis has been indicated) that modify walking capacity;
- pathologies that modify the balance (neurological and/or vestibular);
- contraindications to the use of medical equipment used in the practice;
- inability to understand and sign informed consent.
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 |
|---|---|---|
| Blood flow restriction combined with electrostimulation.Participants will perform 30 minutes of blood flow restriction once a day during electrostimulation of the quadriceps of the operated limb. | Device | Blood flow restriction and Electrostimulation (GEL) |
Primary outcome
Maximum quadriceps strength of the operated limb
Time frame: From the second to the tenth day post surgery.
Maximum quadriceps strength, measured with a dynamometer and expressed in kilograms
3 secondary outcomes
Functional Capacities
Time frame: From the second to the tenth day post surgery.
Functional Strength
Time frame: From the second to the tenth day post surgery.
Walking autonomy
Time frame: From the second to the tenth day post surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Results publication: PubMed 39120683Praetorius A. [Blood flow restriction training (BFRT) in patients before and after total knee arthroplasty]. Orthopadie (Heidelb). 2024 Nov;53(11):853-857. doi: 10.1007/s00132-024-04543-1. Epub 2024 Aug 9. German.
- Results publication: PubMed 39702276Conference Proceedings for the 10th Annual Meeting of Arthroplasty Society in Asia (ASIA), 26th Annual Meeting of the Thai Hip and Knee Society (THKS), and the 16th Annual Meeting of the ASEAN Arthroplasty Association (AAA). Arthroplasty. 2024 Dec 20;6(Suppl 1):62. doi: 10.1186/s42836-024-00286-8. No abstract available.
- Results publication: PubMed 34406084Wengle L, Migliorini F, Leroux T, Chahal J, Theodoropoulos J, Betsch M. The Effects of Blood Flow Restriction in Patients Undergoing Knee Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Aug;50(10):2824-2833. doi: 10.1177/03635465211027296. Epub 2021 Aug 18.
- Results publication: PubMed 37214015De Renty C, Forelli F, Mazeas J, Kakavas G, Hewett TE, Korakakis V. Knee Loading With Blood Flow Restriction Can Enhance Recovery After Total Knee Arthroplasty. Cureus. 2023 Apr 20;15(4):e37895. doi: 10.7759/cureus.37895. eCollection 2023 Apr.
- Results publication: PubMed 35508279Zhang T, Wang X, Wang J. Effect of blood flow restriction combined with low-intensity training on the lower limbs muscle strength and function in older adults: A meta-analysis. Exp Gerontol. 2022 Jul;164:111827. doi: 10.1016/j.exger.2022.111827. Epub 2022 May 1.
- Results publication: PubMed 36497769Chang H, Yao M, Chen B, Qi Y, Zhang J. Effects of Blood Flow Restriction Combined with Low-Intensity Resistance Training on Lower-Limb Muscle Strength and Mass in Post-Middle-Aged Adults: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Nov 25;19(23):15691. doi: 10.3390/ijerph192315691.
- Results publication: PubMed 35464074Das A, Paton B. Is There a Minimum Effective Dose for Vascular Occlusion During Blood Flow Restriction Training? Front Physiol. 2022 Apr 8;13:838115. doi: 10.3389/fphys.2022.838115. eCollection 2022.
- Results publication: PubMed 32256374Freitas EDS, Miller RM, Heishman AD, Ferreira-Junior JB, Araujo JP, Bemben MG. Acute Physiological Responses to Resistance Exercise With Continuous Versus Intermittent Blood Flow Restriction: A Randomized Controlled Trial. Front Physiol. 2020 Mar 17;11:132. doi: 10.3389/fphys.2020.00132. eCollection 2020.
- Results publication: PubMed 30475660Barber-Westin S, Noyes FR. Blood Flow-Restricted Training for Lower Extremity Muscle Weakness due to Knee Pathology: A Systematic Review. Sports Health. 2019 Jan/Feb;11(1):69-83. doi: 10.1177/1941738118811337. Epub 2018 Nov 26.
- Results publication: PubMed 22982712Loenneke JP, Abe T, Wilson JM, Thiebaud RS, Fahs CA, Rossow LM, Bemben MG. Blood flow restriction: an evidence based progressive model (Review). Acta Physiol Hung. 2012 Sep;99(3):235-50. doi: 10.1556/APhysiol.99.2012.3.1.
- Results publication: PubMed 34228788Bielitzki R, Behrendt T, Behrens M, Schega L. Time to Save Time: Beneficial Effects of Blood Flow Restriction Training and the Need to Quantify the Time Potentially Saved by Its Application During Musculoskeletal Rehabilitation. Phys Ther. 2021 Oct 1;101(10):pzab172. doi: 10.1093/ptj/pzab172.
- Results publication: PubMed 25430600Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1.
- Individual participant dataSharing planned: Yes. On justified request and in anonymised form.
Related trials for Osteo Arthritis Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
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.
luca Marin, PhD principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction combined with electrostimulation. in people with Osteo Arthritis Knee, run by University of Pavia at 1 site in Italy.
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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 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 Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Maximum quadriceps strength of the operated limb (time frame: From the second to the tenth day post surgery.). 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 NCT07141316, which also lists 17 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 26 Aug 2025.