Diabetic FootSOLEFUL1NCT05380544
Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers
A study testing Extracorporeal Shockwave Therapy in people with Diabetic Foot, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Summary of the problem: Diabetes has been described as the fastest growing health crisis of our time. It currently affects more than 4.5million people in the UK. The direct cost to the NHS is already over £1 billion per year. One of the commonest complications of diabetes are foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Extracorporeal Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2022to 1 May 2032
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one unhealed diabetic foot ulcer below the level of the medial malleoli that has been present for more than 4 weeks
- Absolute toe pressure greater than or equal to 50mmHg or an Ankle Pressure Brachial Index (ABPI) equal to or greater than 0.7(24, 25)
- Capacity to consent to participate in the trial and given written informed consent
- Willing to be randomised to either sham, low-dose or high-dose ESWT
- Willing to consent to photography of the index DFU
- Willing to comply with the follow up schedule
Who cannot join
- Interdigital index ulcer. This is because the ESWT delivery paddle does not fit between digits.
- Currently on or planned treatment for osteomyelitis.
- Currently taking any therapeutic anticoagulation medications. This includes novel oral anticoagulants, therapeutic doses of heparin and vitamin-K antagonists. This is a contraindication to ESWT.
- Diagnosis of malignancy in the treatment area or haematological, disseminated or lymphatic malignancy. This is a contraindication to ESWT.
- All who are pregnant, trying to conceive or breastfeeding. This is a contraindication to ESWT.
- Active participants in other trials that may conflict with the study outcomes, for example any other wound care trials.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
About this study
Official title: Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers: A Pilot 3-Arm Randomised Control Trial and Qualitative Study (SOLEFUL).
Summary of the problem:
Diabetes has been described as the fastest growing health crisis of our time. It currently affects more than 4.5million people in the UK. The direct cost to the NHS is already over £1 billion per year. One of the commonest complications of diabetes are foot ulcers. Despite current best treatment, these ulcers can be very difficult to heal, often taking months to heal and some never do. Even after healing ulcers return in up to 60% of people. In England someone undergoes an amputation of part of their foot every 2 hours and every 4 hours someone loses their leg due to diabetic foot ulcers. People are rarely able to be as active as before. This seriously affects their work, finances and quality of life.
Read more
Research into improved treatments are a national priority. These treatments need to be safe, effective, tolerable for patients and value for money. Preliminary research has identified shockwave therapy as a promising new treatment in which high-power soundwaves (similar to ultrasound) are delivered to the ulcer. This may make ulcers heal faster. However, the effectiveness of shockwave therapy and the optimum dose is unknown.
The aim of the study:
- To carry out a preliminary (pilot) trial comparing sham (not active) shockwaves, low number of shockwaves and high number of shockwaves on diabetic foot ulcer healing
- To understand beliefs, concerns, ideas and experience of shockwave therapy amongst patients and clinicians
- To investigate the cost effectiveness (value for money) of shockwave therapy
Methods
- Pilot Trial: Ninety patients with DFU will be randomly assigned to one of three treatment groups:
- High dose shockwave treatment
- Low dose shockwave treatment
- "Sham" shockwave treatment
Each treatment will be delivered in 3x30minute sessions in a 7-day period. Face-to-face follow up appointments will take place 1, 2, 3 and 6 months after treatment to measure ulcer healing and changes in quality-of-life.
Interviews Interviews to explore patient opinion of shockwave therapy, experience in taking part in the trial, reasons patients do not want to take part and clinician attitudes to shockwave therapy
Read the detailed description
There is an urgent need for better treatments for diabetic foot ulcers. Despite current best treatment, diabetic foot ulcers can be very difficult to heal, often taking months to heal and some never do. Even after healing ulcers return in up to 60% of people. In England someone undergoes an amputation of part of their foot every 2 hours and every 4 hours someone loses their leg due to diabetic foot ulcers. People are rarely able to be as active as before. This seriously affects their work, finances and quality of life.
This research is going to look at a new therapy called Extracorporeal Shockwave Therapy. Extracorporeal shockwave therapy (high power soundwaves) is a non-invasive treatment that is delivered directly to the ulcer and may improve healing. However, the effectiveness of shockwave therapy and the optimum dose is unknown. We will investigate if shockwave therapy improves diabetic foot ulcer healing. To do this we will undertake a randomised controlled trial. The trial will randomly allocate people (who are eligible to take part and consent) into one of three groups: sham shockwave therapy, low dose shockwave therapy and high dose shockwave therapy. The patient will not know which group they are in. The researcher collecting wound data will not know which group the patient is in. This is to ensure we and the patient do not influence the results of the study. This is a rigorous way of comparing new treatments to existing ones.
The purpose of the pilot trial is to provide information to be able to repeat this trial again with a larger number of people. This pilot trial will help identify any problems and address any issues before the main trial starts. This minimises the risk of wasting money and people's time.
The aim of this study is to:
- Carry out a preliminary (pilot) trial comparing sham (not active) shockwave therapy, low number of shockwaves and high number of shockwaves on diabetes foot ulcers
- To understand beliefs, concerns, ideas and experience of shockwave therapy amongst patients and clinicians
The research has been co-designed by patients and their families with experience of diabetic foot ulcers.
Pilot Trial:
The aim of the pilot trial is to see whether we can recruit enough patients to the study, how many patients remain in the study and reasons why patients leave the trial. It will also test whether we are collecting the information (data) in the right way to answer the research question. This is to make sure that the main trial is successful. Ninety patients who have a diabetic foot ulcer will be randomly assigned to one of the three treatment groups:
- High dose shockwave therapy
- Low dose shockwave therapy
- 'Sham' shockwave therapy
Each treatment will be delivered in a 3x30minute sessions over a 7 day period. All patients will receive usual ulcer care. Face to face follow up appointments will be at 6 weeks, 12 weeks and 24 weeks after study entry to measure ulcer healing, changes in quality of life and health resource use.
Interviews: Patients who are eligible to take part in the trial will be invited to an interview, to explore their reasons for (or for not) taking part, experience undergoing shockwave therapy and thoughts about being in the trial. This is to identify aspects of the trial which patients considered positive/negative so improvements can be made to the main trial. It will also help to improve the main trial and ensure our research is inclusive. Informal interviews, lasting around 30minutes, will be undertaken to explore patient opinion of shockwave therapy, experience of taking part in the trial, reasons patients do not want to take part and clinician attitudes to shockwave therapy. 24 patients and 8 clinicians will be invited to take part.
- Conditions
- Diabetic Foot
- Being tested
- Extracorporeal Shockwave Therapy
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TherapyDevice
ESWT will be given at 0.1mJ/mm2, 5 pulses/second and penetration of 5mm. Each intervention will be delivered in 3x30minute sessions over 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Sham shockwave therapy | Sham comparator | Sham shockwave therapy in standard ulcer care. Receives: Device: Extracorporeal Shockwave Therapy |
| Low dose shockwave therapy | Active comparator | 100 shocks per cm2 plus standard ulcer care Receives: Device: Extracorporeal Shockwave Therapy |
| High dose shockwave therapy | Active comparator | 500 shocks per cm2 plus standard ulcer care Receives: Device: Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility ratio and recruitment ratio
Number eligible patients/number patients screened / recruited
Measured: 19 months
Adherence to treatment
Number participants who completed the treatment protocol/number participants in the trial.
Measured: 19 months
Percentage of missing data at each follow up point
Number of missing data points over number of data points x100
Measured: 24 weeks
Follow up rates
No. of participants who attended each follow-up appointments / no. of follow-up appointments .
Measured: 6 weeks
Follow up rates
No. of participants who attended each follow-up appointments / no. of follow-up
Measured: 12 weeks
Follow up rates
No. of participants who attended each follow-up appointments / no. of follow-up
Measured: 24 weeks
Patient and clinician acceptability of the trial process and ESWT
Semi-structured in depth interviews
Measured: 24 weeks
Secondary outcomes (10)
Time to DFU healing
Time taken for ulcer to heal
Measured: 24 weeks
Proportion of DFUs healed at 6 months
The number of ulcers healed / total no. of ulcers healed in the trial
Measured: 24 weeks
Reduction in ulcer size at each study visit
% reduction in ulcer size
Measured: 24 weeks
Quality of life questionnaires
EQ-5L
Measured: 24 weeks
Quality of life questionnaires
DFUS
Measured: 24 weeks
Quality of life questionnaires
WoundQol
Measured: 24 weeks
Adverse events
Instance of amputation, infection, mortality, side effects, re-hospitalisation
Measured: 24 weeks
Cost differences between ESWT and standard care alone
Incremental Cost Effectiveness Ratio
Measured: 24 weeks
Validity, reliability and responsiveness of WoundQol in patients with a DFU
To test WoundQol-14 reliability of the questionnaire in patients with a diabetic foot ulcer, participants will be asked to complete the questionnaire 3 days before the next follow-up appointment. The WoundQol-14 questionnaire will be repeated at the follow-up appointment. We will also test the validity of using WoundQol-14 over the telephone in patients who struggle to read (for example, due to diabetic retinopathy
Measured: 24 weeks
Validity, reliability and responsiveness of virtual follow-up for wound healing in research
To test the feasibility, validity, reliability and responsiveness of virtual follow-up participants will be asked to send a photograph of their ulcer or ulcer site (if healed) 3 days before their follow up appointment to virtually assess the wound. Photographs are anticipated to be taken on the participant's smartphone by either themselves, a family member, friend or the community healthcare professional at dressing changes.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start13 Apr 2022
- Primary completion31 Oct 2023
- Study completion1 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies 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
- Model description
- Pilot RCT and Qualitative study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Louise Hitchman, MBBSMRCSMSc, Principal investigator, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380544
- Sponsor's protocol ID
- R2743
- Other IDs
- 301807, 311664
- Acronym
- SOLEFUL1
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2022
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on request.
Publications
Hitchman L, Iglesias C, Russell D, Smith G, Twiddy M, Chetter IC. A Pilot Three Arm Randomised Controlled Trial and Qualitative Study of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcer Healing (SOLEFUL): A Study Protocol. Int Wound J. 2025 Apr;22(4):e70176. doi: 10.1111/iwj.70176.
PubMed 40159429
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers: A Pilot 3-Arm Randomised Control Trial and Qualitative Study (SOLEFUL).
- ClinicalTrials.gov ID
- NCT05380544
- Acronym / sponsor ID
- SOLEFUL1 / R2743
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 1 May 2032 (estimated)
- First posted
- 19 May 2022 (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.
Summary of the problem:
Diabetes has been described as the fastest growing health crisis of our time. It currently affects more than 4.5million people in the UK. The direct cost to the NHS is already over £1 billion per year. One of the commonest complications of diabetes are foot ulcers. Despite current best treatment, these ulcers can be very difficult to heal, often taking months to heal and some never do. Even after healing ulcers return in up to 60% of people. In England someone undergoes an amputation of part of their foot every 2 hours and every 4 hours someone loses their leg due to diabetic foot ulcers. People are rarely able to be as active as before. This seriously affects their work, finances and quality of life.
Research into improved treatments are a national priority. These treatments need to be safe, effective, tolerable for patients and value for money. Preliminary research has identified shockwave therapy as a promising new treatment in which high-power soundwaves (similar to ultrasound) are delivered to the ulcer. This may make ulcers heal faster. However, the effectiveness of shockwave therapy and the optimum dose is unknown.
The aim of the study:
- To carry out a preliminary (pilot) trial comparing sham (not active) shockwaves, low number of shockwaves and high number of shockwaves on diabetic foot ulcer healing
- To understand beliefs, concerns, ideas and experience of shockwave therapy amongst patients and clinicians
- To investigate the cost effectiveness (value for money) of shockwave therapy
Methods
- Pilot Trial: Ninety patients with DFU will be randomly assigned to one of three treatment groups:
- High dose shockwave treatment
- Low dose shockwave treatment
- "Sham" shockwave treatment
Each treatment will be delivered in 3x30minute sessions in a 7-day period. Face-to-face follow up appointments will take place 1, 2, 3 and 6 months after treatment to measure ulcer healing and changes in quality-of-life.
Interviews Interviews to explore patient opinion of shockwave therapy, experience in taking part in the trial, reasons patients do not want to take part and clinician attitudes to shockwave therapy
Detailed description
There is an urgent need for better treatments for diabetic foot ulcers. Despite current best treatment, diabetic foot ulcers can be very difficult to heal, often taking months to heal and some never do. Even after healing ulcers return in up to 60% of people. In England someone undergoes an amputation of part of their foot every 2 hours and every 4 hours someone loses their leg due to diabetic foot ulcers. People are rarely able to be as active as before. This seriously affects their work, finances and quality of life.
This research is going to look at a new therapy called Extracorporeal Shockwave Therapy. Extracorporeal shockwave therapy (high power soundwaves) is a non-invasive treatment that is delivered directly to the ulcer and may improve healing. However, the effectiveness of shockwave therapy and the optimum dose is unknown. We will investigate if shockwave therapy improves diabetic foot ulcer healing. To do this we will undertake a randomised controlled trial. The trial will randomly allocate people (who are eligible to take part and consent) into one of three groups: sham shockwave therapy, low dose shockwave therapy and high dose shockwave therapy. The patient will not know which group they are in. The researcher collecting wound data will not know which group the patient is in. This is to ensure we and the patient do not influence the results of the study. This is a rigorous way of comparing new treatments to existing ones.
The purpose of the pilot trial is to provide information to be able to repeat this trial again with a larger number of people. This pilot trial will help identify any problems and address any issues before the main trial starts. This minimises the risk of wasting money and people's time.
The aim of this study is to:
- Carry out a preliminary (pilot) trial comparing sham (not active) shockwave therapy, low number of shockwaves and high number of shockwaves on diabetes foot ulcers
- To understand beliefs, concerns, ideas and experience of shockwave therapy amongst patients and clinicians
The research has been co-designed by patients and their families with experience of diabetic foot ulcers.
Pilot Trial:
The aim of the pilot trial is to see whether we can recruit enough patients to the study, how many patients remain in the study and reasons why patients leave the trial. It will also test whether we are collecting the information (data) in the right way to answer the research question. This is to make sure that the main trial is successful. Ninety patients who have a diabetic foot ulcer will be randomly assigned to one of the three treatment groups:
- High dose shockwave therapy
- Low dose shockwave therapy
- 'Sham' shockwave therapy
Each treatment will be delivered in a 3x30minute sessions over a 7 day period. All patients will receive usual ulcer care. Face to face follow up appointments will be at 6 weeks, 12 weeks and 24 weeks after study entry to measure ulcer healing, changes in quality of life and health resource use.
Interviews: Patients who are eligible to take part in the trial will be invited to an interview, to explore their reasons for (or for not) taking part, experience undergoing shockwave therapy and thoughts about being in the trial. This is to identify aspects of the trial which patients considered positive/negative so improvements can be made to the main trial. It will also help to improve the main trial and ensure our research is inclusive. Informal interviews, lasting around 30minutes, will be undertaken to explore patient opinion of shockwave therapy, experience of taking part in the trial, reasons patients do not want to take part and clinician attitudes to shockwave therapy. 24 patients and 8 clinicians will be invited to take part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Pilot RCT and Qualitative study
| Arm | Type | Receives |
|---|---|---|
| Sham shockwave therapy | Sham comparator | Device: Extracorporeal Shockwave TherapySham shockwave therapy in standard ulcer care. |
| Low dose shockwave therapy | Active comparator | Device: Extracorporeal Shockwave Therapy100 shocks per cm2 plus standard ulcer care |
| High dose shockwave therapy | Active comparator | Device: Extracorporeal Shockwave Therapy500 shocks per cm2 plus standard ulcer care |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least one unhealed diabetic foot ulcer below the level of the medial malleoli that has been present for more than 4 weeks
- Absolute toe pressure greater than or equal to 50mmHg or an Ankle Pressure Brachial Index (ABPI) equal to or greater than 0.7(24, 25)
- Capacity to consent to participate in the trial and given written informed consent
- Willing to be randomised to either sham, low-dose or high-dose ESWT
- Willing to consent to photography of the index DFU
Key exclusion criteria (6 listed)
- Interdigital index ulcer. This is because the ESWT delivery paddle does not fit between digits.
- Currently on or planned treatment for osteomyelitis.
- Currently taking any therapeutic anticoagulation medications. This includes novel oral anticoagulants, therapeutic doses of heparin and vitamin-K antagonists. This is a contraindication to ESWT.
- Diagnosis of malignancy in the treatment area or haematological, disseminated or lymphatic malignancy. This is a contraindication to ESWT.
- All who are pregnant, trying to conceive or breastfeeding. This is a contraindication to ESWT.
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 |
|---|---|---|
| Extracorporeal Shockwave TherapyESWT will be given at 0.1mJ/mm2, 5 pulses/second and penetration of 5mm. Each intervention will be delivered in 3x30minute sessions over 7 days. | Device | High dose shockwave therapy, Low dose shockwave therapy, Sham shockwave therapy |
Primary outcome
Eligibility ratio and recruitment ratio
Time frame: 19 months
Number eligible patients/number patients screened / recruited
Adherence to treatment
Time frame: 19 months
Number participants who completed the treatment protocol/number participants in the trial.
Percentage of missing data at each follow up point
Time frame: 24 weeks
Number of missing data points over number of data points x100
Follow up rates
Time frame: 6 weeks
No. of participants who attended each follow-up appointments / no. of follow-up appointments .
Follow up rates
Time frame: 12 weeks
No. of participants who attended each follow-up appointments / no. of follow-up
Follow up rates
Time frame: 24 weeks
No. of participants who attended each follow-up appointments / no. of follow-up
Patient and clinician acceptability of the trial process and ESWT
Time frame: 24 weeks
Semi-structured in depth interviews
10 secondary outcomes
Time to DFU healing
Time frame: 24 weeks
Proportion of DFUs healed at 6 months
Time frame: 24 weeks
Reduction in ulcer size at each study visit
Time frame: 24 weeks
Quality of life questionnaires
Time frame: 24 weeks
Quality of life questionnaires
Time frame: 24 weeks
Quality of life questionnaires
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
Cost differences between ESWT and standard care alone
Time frame: 24 weeks
Validity, reliability and responsiveness of WoundQol in patients with a DFU
Time frame: 24 weeks
Validity, reliability and responsiveness of virtual follow-up for wound healing in research
Time frame: 24 weeks
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 18 Jun 2026.
- Derived from this study: PubMed 40159429Hitchman L, Iglesias C, Russell D, Smith G, Twiddy M, Chetter IC. A Pilot Three Arm Randomised Controlled Trial and Qualitative Study of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcer Healing (SOLEFUL): A Study Protocol. Int Wound J. 2025 Apr;22(4):e70176. doi: 10.1111/iwj.70176.
- Individual participant dataSharing planned: Yes. Data on request.
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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.
Louise Hitchman, MBBSMRCSMSc principal investigator
University of Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Therapy in people with Diabetic Foot, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 6 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 18 Jun 2026. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Eligibility ratio and recruitment ratio (time frame: 19 months). The study lists 7 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 NCT05380544, which also lists 1 linked publication.
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 18 Jun 2026.