Aerobic Physical ExerciseVESSEL-FITNCT07248137
Acute Effects of Exercise in Peripheral Arterial Disease Patients
A study testing Aerobic exercise, Traditional strength exercise and Circuit strength exercise in people with Aerobic Physical Exercise and Traditional Strength Exercise, run by European University Miguel de Cervantes.
Trial summary
Peripheral arterial disease (PAD) affects over 200 million people worldwide and is caused by narrowing of the arteries. Intermittent claudication, characterized by pain when walking, is its main symptom. Despite the proven benefits of exercise, there is no optimal protocol for treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aerobic Physical Exercise, Traditional Strength Exercise, Circuit Strength Exercise
- What is being tested?
- Aerobic exercise, Traditional strength exercise and Circuit strength exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Mar 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older.
- Patients diagnosed with peripheral arterial disease at grade IIa or IIb according to the Leriche-Fontaine classification.
Who cannot join
- Patients with dementia or cognitive impairment.
- Patients with recent major surgery (≤12 months) or lower limb amputations.
- Patients institutionalized in healthcare facilities.
- Patients dependent on a wheelchair.
- Patients with any other condition contraindicating participation in an exercise program.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acute Effects of Different Physical Exercise Conditions in Patients With Peripheral Arterial Disease
Peripheral arterial disease (PAD) affects over 200 million people worldwide and is caused by narrowing of the arteries. Intermittent claudication, characterized by pain when walking, is its main symptom. Despite the proven benefits of exercise, there is no optimal protocol for treatment. To analyze the effects of different exercise conditions on proteomic and physiological markers in patients with PAD and to determine their preferences regarding exercise conditions. A clinical cross-over study with four randomized experimental conditions (aerobic training, traditional strength training, circuit training and control) will be conducted. Patients with grade IIa-IIb PAD according to the Leriche-Le Fontaine scale will be recruited from the Department of Angiology and Vascular Surgery Department of the Hospital Clínico Universitario de Valladolid. In each experimental session, measurements of cardiorespiratory capacity, post-exercise oxygen debt, ankle-brachial index, blood flow, peripheral oxygen saturation, perceived exertion, heart rate variability and blood proteome changes will be performed.
- Conditions
- Aerobic Physical Exercise, Traditional Strength Exercise, Circuit Strength Exercise, Control
- Being tested
- Aerobic exercise, Traditional strength exercise, Circuit strength exercise
- Keywords
- Intermittent claudication, Proteomic markers, Vascular disease, Physiotherapy
- Medical subject headings
- Intermittent Claudication, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Intermittent walking will be performed on a treadmill (F2W DUAL, BHFitness®, Spain). There will be 8 sets of 2 minutes in duration at an intensity equivalent to the level at which the patient experienced claudication symptoms. The recovery period between each set will be two minutes. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland).
Traditional strength exerciseOther
Two sets will be performed with a moderate-to-high effort level (15-16 repetitions out of 20RM) consisting of 6 multi-joint exercises. The recovery period after each set will be two minutes of passive rest. Each participant will be asked to move the load as quickly as possible during each repetition. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland).
Circuit strength exerciseOther
Two sets (rounds) will be performed with a moderate-to-high effort level (15-16 repetitions out of 20RM) in a circuit consisting of 6 multi-joint exercises. The recovery time between exercises will be the minimum required to change exercises, and the recovery between sets (rounds) will be two minutes of passive rest. Each participant will be asked to move the load as quickly as possible during each repetition. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland).
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Intermittent walking will be performed on a treadmill (F2W DUAL, BHFitness®, Spain). There will be 8 sets of 2 minutes in duration at an intensity equivalent to the level at which the patient experienced claudication symptoms. The recovery period between each set will be two minutes. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland). Receives: Other: Aerobic exercise |
| Traditional strength exercise | Experimental | Two sets will be performed with a moderate-to-high effort level (15-16 repetitions out of 20RM) consisting of 6 multi-joint exercises. The recovery period after each set will be two minutes of passive rest. Each participant will be asked to move the load as quickly as possible during each repetition. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland). Receives: Other: Traditional strength exercise |
| Circuit strength exercise | Experimental | Two sets (rounds) will be performed with a moderate-to-high effort level (15-16 repetitions out of 20RM) in a circuit consisting of 6 multi-joint exercises. The recovery time between exercises will be the minimum required to change exercises, and the recovery between sets (rounds) will be two minutes of passive rest. Each participant will be asked to move the load as quickly as possible during each repetition. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland). Receives: Other: Circuit strength exercise |
| Control | No intervention | Control. No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Flow
An ultrasound machine will be used to measure blood flow in the femoral artery, quantifying changes in the velocity and diameter of the artery in the lower extremity with the lowest ABI. Blood flow measurements will be conducted with the participant in a supine position. During the first experimental visit, the measurement site will be determined, where all measurements will take place. This measurement site corresponds to the common femoral artery, just below the inguinal ligament, and approximately 2 cm above the bifurcation into the superficial and deep femoral arteries.
Measured: Week 1 (baseline), Weeks 2-4 (15 minutes post-intervention)
Peripheral oxygen saturation
Changes in peripheral oxygenation levels in the gastrocnemius will be evaluated during physical exercise. For this purpose, near-infrared spectroscopy (NIRS) will be used, which utilizes a wavelength of 700-900 nm to assess the concentration of oxygenated and deoxygenated hemoglobin and the total blood volume. The NIRS device MOXY Monitor (Moxy, Fortiori Design LLC, Minneapolis, MN, USA) will be used.
Measured: Week 1 (baseline), Weeks 2-4 (during each intervention session)
Heart rate variability
By monitoring the heart rate of participants, heart rate variability (HRV) will be assessed, which reflects the variation in the time intervals between beats (R-R intervals) and serves as a useful tool for monitoring patient health, as it estimates the balance between the sympathetic and parasympathetic branches of the autonomic nervous system. To evaluate HRV, a Polar H10 heart rate monitor (Polar Electro Oy, Kempele, Finland) and a mobile application, specifically Elite HRV, will be used. Heart rate variability will be monitored daily during the week leading up to the initial assessment visits. Participants will be instructed to take the measurement for the first 5 minutes after waking up and while fasting.
Measured: Week 1 (baseline), Weeks 2-4 (during intervention and 24, 48, and 72 hours post-intervention)
Proteomics
A blood sample will be collected during the last 5 minutes of the pre-session and after completing the experimental condition, just before a 15-minute post-session rest. Venous blood will be drawn from the antecubital vein and stored at 4°C to prevent clotting and minimize protein degradation. Samples will be centrifuged at 1500 g for 10 minutes at 4°C, discarding the remaining sample. Ten microliters of protease inhibitor will be added to each 1.0 ml plasma aliquot, stored at -80°C for later analysis, with only one freeze-thaw cycle permitted. All samples will be prepared within 1 hour of collection and must show no hemolysis.
Peptide identification will be performed using Proteome Discoverer (version 2.1.0.81) and SEQUEST-HT, analyzing data in the Uniprot database (January 25, 2024; 20,433 reviewed entries). Identified peptides with a false discovery rate (FDR) of 1% or less will quantify the relative abundance of each protein.
Measured: Weeks 2-4 (5 minutes prior to exercise and 5 minutos post-intervention)
Secondary outcomes (3)
Post-exercise oxygen debt
Post-exercise oxygen debt (EPOC) will be calculated every minute for 12 minutes following the completion of exercise using the following formula: EPOC (L·min-¹) = post-exercise VO2 (L·min-¹) - resting VO2 (L·min-¹). Subsequently, EPOC will be converted into energy expenditure with the conversion of 1L of O2 = 4.64 kcal to exclude the rapid glycolytic resynthesis of adenosine triphosphate (ATP) as part of the conversion of O2 consumption into energy expenditure (EE).
Measured: Weeks 2-4 (after every intervention session)
Perceived exertion
During the four experimental conditions, perceived exertion will be monitored using the Rating of Perceived Exertion (RPE) scale. The RPE will be recorded after each set or circuit round. Immediately after completing the last set of each condition, participants will be asked to indicate their perceived exertion for the entire session.
Scales go from 0 (no exertion) to 10 (maximal exertion possible).
Measured: Weeks 2-4 (right after every intervention session and 24, 48, and 72 hours post-intervention)
Satisfaction with the type of training
At the end of each session, satisfaction will be evaluated using a numerical scale from 0 to 10, where the highest score indicates maximum satisfaction with the type of training.
Measured: Weeks 2-4 (right after every intervention session and 24 and 48 post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic Physical ExerciseStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University Miguel de Cervantes
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid. Angiology and Vascular Surgery Department.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248137
- Sponsor's protocol ID
- PI-DOC009- VESSEL-FIT
- Acronym
- VESSEL-FIT
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Different Physical Exercise Conditions in Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT07248137
- Acronym / sponsor ID
- VESSEL-FIT / PI-DOC009- VESSEL-FIT
- Conditions
- Aerobic Physical Exercise, Traditional Strength Exercise, Circuit Strength Exercise, Control
- Keywords
- Intermittent claudication, Proteomic markers, Vascular disease, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- European University Miguel de CervantesUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid. Angiology and Vascular Surgery Department.
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 25 Nov 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.
Peripheral arterial disease (PAD) affects over 200 million people worldwide and is caused by narrowing of the arteries. Intermittent claudication, characterized by pain when walking, is its main symptom. Despite the proven benefits of exercise, there is no optimal protocol for treatment. To analyze the effects of different exercise conditions on proteomic and physiological markers in patients with PAD and to determine their preferences regarding exercise conditions. A clinical cross-over study with four randomized experimental conditions (aerobic training, traditional strength training, circuit training and control) will be conducted. Patients with grade IIa-IIb PAD according to the Leriche-Le Fontaine scale will be recruited from the Department of Angiology and Vascular Surgery Department of the Hospital Clínico Universitario de Valladolid. In each experimental session, measurements of cardiorespiratory capacity, post-exercise oxygen debt, ankle-brachial index, blood flow, peripheral oxygen saturation, perceived exertion, heart rate variability and blood proteome changes will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Other: Aerobic exerciseIntermittent walking will be performed on a treadmill (F2W DUAL, BHFitness®, Spain). There will be 8 sets of 2 minutes in duration at an intensity equivalent to the level at which the patient experienced claudication symptoms. The recovery period between each set will be two minutes. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland). |
| Traditional strength exercise | Experimental | Other: Traditional strength exerciseTwo sets will be performed with a moderate-to-high effort level (15-16 repetitions out of 20RM) consisting of 6 multi-joint exercises. The recovery period after each set will be two minutes of passive rest. Each participant will be asked to move the load as quickly as possible during each repetition. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland). |
| Circuit strength exercise | Experimental | Other: Circuit strength exerciseTwo sets (rounds) will be performed with a moderate-to-high effort level (15-16 repetitions out of 20RM) in a circuit consisting of 6 multi-joint exercises. The recovery time between exercises will be the minimum required to change exercises, and the recovery between sets (rounds) will be two minutes of passive rest. Each participant will be asked to move the load as quickly as possible during each repetition. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland). |
| Control | No intervention | –Control. No intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be 18 years of age or older.
- Patients diagnosed with peripheral arterial disease at grade IIa or IIb according to the Leriche-Fontaine classification.
Key exclusion criteria (5 listed)
- Patients with dementia or cognitive impairment.
- Patients with recent major surgery (≤12 months) or lower limb amputations.
- Patients institutionalized in healthcare facilities.
- Patients dependent on a wheelchair.
- Patients with any other condition contraindicating participation in an exercise program.
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 |
|---|---|---|
| Aerobic exerciseIntermittent walking will be performed on a treadmill (F2W DUAL, BHFitness®, Spain). There will be 8 sets of 2 minutes in duration at an intensity equivalent to the level at which the patient experienced claudication symptoms. The recovery period between each set will be two minutes. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland). | Other | Aerobic exercise |
| Traditional strength exerciseTwo sets will be performed with a moderate-to-high effort level (15-16 repetitions out of 20RM) consisting of 6 multi-joint exercises. The recovery period after each set will be two minutes of passive rest. Each participant will be asked to move the load as quickly as possible during each repetition. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland). | Other | Traditional strength exercise |
| Circuit strength exerciseTwo sets (rounds) will be performed with a moderate-to-high effort level (15-16 repetitions out of 20RM) in a circuit consisting of 6 multi-joint exercises. The recovery time between exercises will be the minimum required to change exercises, and the recovery between sets (rounds) will be two minutes of passive rest. Each participant will be asked to move the load as quickly as possible during each repetition. All training sessions will conclude with a cool-down period of 5 minutes of walking at 50-60% of peak heart rate, followed by 3 minutes of joint mobility exercises. Throughout the session, heart rate will be continuously monitored using a heart rate monitor (Polar H10, Polar Electro Ltd., Kempele, Finland) and the Polar Team application (Polar Electro Ltd., Kempele, Finland). | Other | Circuit strength exercise |
Primary outcome
Blood Flow
Time frame: Week 1 (baseline), Weeks 2-4 (15 minutes post-intervention)
An ultrasound machine will be used to measure blood flow in the femoral artery, quantifying changes in the velocity and diameter of the artery in the lower extremity with the lowest ABI. Blood flow measurements will be conducted with the participant in a supine position. During the first experimental visit, the measurement site will be determined, where all measurements will take place. This measurement site corresponds to the common femoral artery, just below the inguinal ligament, and approximately 2 cm above the bifurcation into the superficial and deep femoral arteries.
Peripheral oxygen saturation
Time frame: Week 1 (baseline), Weeks 2-4 (during each intervention session)
Changes in peripheral oxygenation levels in the gastrocnemius will be evaluated during physical exercise. For this purpose, near-infrared spectroscopy (NIRS) will be used, which utilizes a wavelength of 700-900 nm to assess the concentration of oxygenated and deoxygenated hemoglobin and the total blood volume. The NIRS device MOXY Monitor (Moxy, Fortiori Design LLC, Minneapolis, MN, USA) will be used.
Heart rate variability
Time frame: Week 1 (baseline), Weeks 2-4 (during intervention and 24, 48, and 72 hours post-intervention)
By monitoring the heart rate of participants, heart rate variability (HRV) will be assessed, which reflects the variation in the time intervals between beats (R-R intervals) and serves as a useful tool for monitoring patient health, as it estimates the balance between the sympathetic and parasympathetic branches of the autonomic nervous system. To evaluate HRV, a Polar H10 heart rate monitor (Polar Electro Oy, Kempele, Finland) and a mobile application, specifically Elite HRV, will be used. Heart rate variability will be monitored daily during the week leading up to the initial assessment visits. Participants will be instructed to take the measurement for the first 5 minutes after waking up and while fasting.
Proteomics
Time frame: Weeks 2-4 (5 minutes prior to exercise and 5 minutos post-intervention)
A blood sample will be collected during the last 5 minutes of the pre-session and after completing the experimental condition, just before a 15-minute post-session rest. Venous blood will be drawn from the antecubital vein and stored at 4°C to prevent clotting and minimize protein degradation. Samples will be centrifuged at 1500 g for 10 minutes at 4°C, discarding the remaining sample. Ten microliters of protease inhibitor will be added to each 1.0 ml plasma aliquot, stored at -80°C for later analysis, with only one freeze-thaw cycle permitted. All samples will be prepared within 1 hour of collection and must show no hemolysis. Peptide identification will be performed using Proteome Discoverer (version 2.1.0.81) and SEQUEST-HT, analyzing data in the Uniprot database (January 25, 2024; 20,433 reviewed entries). Identified peptides with a false discovery rate (FDR) of 1% or less will quantify the relative abundance of each protein.
3 secondary outcomes
Post-exercise oxygen debt
Time frame: Weeks 2-4 (after every intervention session)
Perceived exertion
Time frame: Weeks 2-4 (right after every intervention session and 24, 48, and 72 hours post-intervention)
Satisfaction with the type of training
Time frame: Weeks 2-4 (right after every intervention session and 24 and 48 post-intervention)
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 1 Dec 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise, Traditional strength exercise and Circuit strength exercise in people with Aerobic Physical Exercise and Traditional Strength Exercise, run by European University Miguel de Cervantes.
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 2 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: opening soon, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Susana López Ortiz, PhD (983001000, slopezo@uemc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Flow (time frame: Week 1 (baseline), Weeks 2-4 (15 minutes post-intervention)). The study lists 4 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 1 Dec 2025.