Subjects With Diabetes and DFU With a Suspicion of DFOBOLBOCNCT06066801
Bedside Bone Biopsy in Diabetic Foot Osteomyelitis
A study testing Bedside blind bone biopsy procedure in people with Subjects With Diabetes and DFU With a Suspicion of DFO, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
During their lifetime, 15 to 25% of patients with diabetes mellitus will develop a Diabetic Foot Ulcer (DFU) related to neuropathy and/or peripheral arterial disease. DFU is the leading cause of non-traumatic lower-extremity amputation worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjects With Diabetes and DFU With a Suspicion of DFO
- What is being tested?
- Bedside blind bone biopsy procedure
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2024to Oct 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for inclusion in this study must fulfill all of the following criteria:
- Aged >18 years
- Diabetes mellitus
- At least one of the following signs of osteomyelitis according to IWGDF 2019 guidelines:
- A positive probe to bone test and abnormalities on plain X-ray suggestive for osteomyelitis Signs of osteomyelitis on CT-scan and/or MRI and/or white blood cell SPECT/CT and/or FDG-PET/CT-scan
- Absence of antibacterial therapy within 14 days before inclusion
Who cannot join
- Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- Urgent need for surgery
- Critical limb ischemia which cannot be corrected by revascularization procedure
- Subjects that (are likely to) undergo surgical or percutaneous revascularization are not excluded
- Antibiotic treatment in the last 15 days before bone biopsy
- Osteomyelitis in the area of the Charcot foot destructive process
Show all 12Show fewer
- Unlikely to live at least 1 year
- Not being able to give informed consent and willing to comply with the research protocol
- Pregnant or breastfeeding women
- Absence of affiliation to French social insurance
- State medical aid (AME)
- Deprivation of liberty, being under a legal protective measure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Bichat - Claude Bernard Hospital
Paris, 75018
Louis Potier, MD, PhD, 01 40 25 88 03, louis.potier@aphp.fr
About this study
Official title: Bedside Bone Biopsy Versus Conventional Bone Biopsy for Management of Diabetic Foot Osteomyelitis: an Open-label Controlled Randomized Non-inferiority Trial
During their lifetime, 15 to 25% of patients with diabetes mellitus will develop a Diabetic Foot Ulcer (DFU) related to neuropathy and/or peripheral arterial disease. DFU is the leading cause of non-traumatic lower-extremity amputation worldwide. Diabetic foot osteomyelitis (DFO), which complicates up to 60% of DFU, is a major trigger of amputation in over 80% of persons with diabetes resulting in subsequent loss of quality of life. It has been shown that medical treatment of DFO may prevent amputations with early diagnosis of osteomyelitis and appropriate use of antibiotics. Empirical antimicrobial treatment is not recommended for DFO as for other chronic infections. Surgically or radiologically acquired bone sample for culture is the reference standard recommended by the International Working Group of Diabetic Foot (IWGDF) to diagnose DFO and to determine the causative bacteria and their susceptibility. However, defining appropriate antimicrobial therapy directed to the causative bacteria in DFO is challenging since it requires bone biopsy (BB) procedures which are underused in clinical practice for various reasons: lack of availability, cost, and delay. Some clinicians also find bone biopsy cumbersome or too invasive.
To overcome these barriers, we have set up for a few years a bedside blind BB procedure performed by diabetologists at the bedside in the clinical ward. Since then, this method has been used in more than 200 patients with DFO in the diabetology departments of Lariboisiere Hospital and Bichat Hospital (Paris). We have recently published our observational data of 79 patients showing that bedside BB is a simple, safe and efficient procedure for the diagnosis of DFO with a similar rate of complete healing at 12 months compared to conventional surgical or radiological bone biopsies. In order to extend and confirm these preliminary and observational results, the aim of this study is to compare the efficiency and safety of bedside BB versus conventional bone biopsy in a randomized controlled trial (RCT) of patients with DFO. Our hypothesis is that bedside BB is non-inferior to conventional bone biopsy in DFO and can be used as a simpler alternative procedure to document DFO
Read the detailed description
During their lifetime, 15 to 25% of patients with diabetes mellitus will develop a Diabetic Foot Ulcer (DFU) related to neuropathy and/or peripheral arterial disease1. DFU is the leading cause of non-traumatic lower-extremity amputation worldwide. DFO, which complicates up to 60% of DFU, is a major trigger of amputation in over 80% of persons with diabetes resulting in subsequent loss of quality of life2. It has been shown that medical treatment of DFO may prevent amputations with early diagnosis of osteomyelitis and appropriate use of antibiotics3. Empirical antimicrobial treatment is not recommended for DFO as for other chronic infections. Surgically or radiologically acquired bone sample for culture is the reference standard recommended by the International Working Group of Diabetic Foot (IWGDF) to diagnose DFO and to determine the causative bacteria and their susceptibility4. However, defining appropriate antimicrobial therapy directed to the causative bacteria in DFO is challenging since it requires bone biopsy (BB) procedures which are underused in clinical practice for various reasons including lack of availability, cost, and delay. Some clinicians also find bone biopsy cumbersome or too invasive.
To overcome these barriers, we have set up for a few years a bedside blind BB procedure performed by a physician at the bedside in the clinical ward. Since then, this method has been used in more than 200 patients with DFO in the diabetology departments of Lariboisiere Hospital and Bichat Hospital (Paris). We have recently published our observational data of 79 patients showing that bedside BB is a simple, safe and efficient procedure for the diagnosis of DFO with a similar rate of complete DFU healing at 12 months compared to conventional surgical or radiological bone biopsies6. In order to extend and confirm these preliminary and observational results, the aim of this study is to compare the efficiency and safety of bedside versus conventional BB in a randomized controlled trial (RCT) of patients with DFO. Our hypothesis is that bedside BB is non inferior to conventional BB in DFO outcomes and can be used as a simpler alternative procedure to document DFO.
The main objective is to demonstrate non-inferiority of beside blind bone biopsy compared to conventional bone biopsy (surgical or radiological) on DFO remission without surgery at 1 year.
The secondary objectives of this study are to:
- compare clinical efficacy between groups of bone biopsy
- compare microbiological culture results between groups
- compare the safety of both procedures
- compare DFO remission according to results of BB (negative or positive)
The health economic of this study are to:
- to estimate total costs for the intervention and total medical costs in each groups
- to estimate total quality adjusted life years (QALYs) based upon EQ5D5L scores
- to calculate the point estimate of the incremental cost utility ratio and estimate the probability of decremental cost effectiveness for the beside blind bone biopsy compared to conventional biopsy.
In this study, we will include subjects with diabetes and DFU with a suspicion of DFO. DFO is a complication of a large amount of DFU and is a major trigger of lower limb amputations. As we will include participants before bacteriological confirmation of DFO through bone biopsy, we will use the clinical and radiological criteria for DFO according to IWGDF 2019 guidelines4.
These criteria include having at least one of the following signs:
- A positive probe to bone test and abnormalities on plain X-ray suggestive for osteomyelitis
- Signs of osteomyelitis on CT-scan and/or MRI and/or white blood cell SPECT/CT and/or 18Fluor-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose-positron emission tomography (FDG-PET)/CT- scan
- Being tested
- Bedside blind bone biopsy procedure
- Keywords
- Bedside bone biopsy, conventional bone biopsy, diabetes, Diabetic Foot Ulcer (DFU), diabetic foot osteomyelitis (DFO)
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside blind bone biopsy procedureProcedure or surgery
It was performed in the patient's room under aseptic conditions. Pain relievers were given orally within the hour preceding the procedure. Superficial anesthesia was performed firstly subcutaneously and then on the periosteum, Inhaled anesthesia was started concomitantly. Following a short incision with a scalpel, the trocar inside a cannula was inserted through healthy skin at a minimum distance of 2 cm from the ulcer edge, close to the bone, preferentially on dorsal foot side. When the trocar was firmly inserted into the bone, it was pulled out from the cannula. Biopsy needle was then slipped into the cannula and twisted into the bone clockwise. Biopsy needle was then pulled out and the bone was pushed out with the ejector pin into a sterile surgical drape and divided in two parts.
| Study group | Role | What they receive |
|---|---|---|
| Bedside blind bone biopsy procedure | Experimental | Bedside blind bone biopsy procedure performed by a physician of the participating center through healthy skin with bone trocar following local and light systemic anesthesia. Samples will be analyzed for microbiology and histopathology Receives: Procedure: Bedside blind bone biopsy procedure |
| Standard bone biopsy procedure | Active comparator | Standard BB procedure (surgical or radiological) performed according to the local standard of care of each participating center and done through healthy skin and under locoregional anesthesia. Samples will be analyzed for microbiology and histopathology Receives: Procedure: Bedside blind bone biopsy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
the remission of DFO
The remission of DFO at 12 months and is defined by a composite criterion as:
- an epithelialized ulcer for 28 consecutive days
- and absence of local inflammation and/or stabilization or improvement of radiologic abnormalities
- and no need for surgery of the foot to treat DFO during follow-up
Measured: 12 months
Secondary outcomes (16)
Clinical efficacy
Remission of DFO at 6 months
Measured: 12 months
Clinical efficacy
Need for surgery for initial DFU during follow-up
Measured: 12 months
Clinical efficacy
Recurrence of DFU during follow-up
Measured: 12 months
Clinical efficacy
Death during follow-up
Measured: 12 months
Clinical efficacy
Number of hospitalizations
Measured: 12 months
Clinical efficacy
length of hospitalizations
Measured: 12 months
Clinical efficacy
Length of stay of the initial hospitalization (in days)
Measured: 12 months
Microbiological results
Number of microorganisms per biopsy
Measured: 12 months
Microbiological results
Number of resistant microorganisms per biopsy
Measured: 12 months
Microbiological results
Total duration of the antibacterial therapy (mean in days)
Measured: 12 months
Occurrence of adverse events during the study
Measured: 12 months
Remission rate of DFO
Remission rate of DFO at 12 months according to microbiological results of BB (positive or negative)
Measured: 12 months
costs: Average costs of the biopsies
Measured: 1 month
costs: Average total 1-year costs
Measured: 12 months
Average 1 year QALY
Measured: 12 months
Incremental cost effectiveness ratio
defined as the difference in average total costs/ average total QALY
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start14 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With Diabetes and DFU With a Suspicion of DFOStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis Potier, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066801
- Sponsor's protocol ID
- PHRC-21-0179
- Other IDs
- 2022-A02754-39
- Acronym
- BOLBOC
- Status last verified
- Nov 2025
- First submitted
- 27 Sep 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Bone Biopsy Versus Conventional Bone Biopsy for Management of Diabetic Foot Osteomyelitis: an Open-label Controlled Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06066801
- Acronym / sponsor ID
- BOLBOC / PHRC-21-0179
- Keywords
- Bedside bone biopsy, conventional bone biopsy, diabetes, Diabetic Foot Ulcer (DFU), diabetic foot osteomyelitis (DFO)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 4 Oct 2023 (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.
During their lifetime, 15 to 25% of patients with diabetes mellitus will develop a Diabetic Foot Ulcer (DFU) related to neuropathy and/or peripheral arterial disease. DFU is the leading cause of non-traumatic lower-extremity amputation worldwide. Diabetic foot osteomyelitis (DFO), which complicates up to 60% of DFU, is a major trigger of amputation in over 80% of persons with diabetes resulting in subsequent loss of quality of life. It has been shown that medical treatment of DFO may prevent amputations with early diagnosis of osteomyelitis and appropriate use of antibiotics. Empirical antimicrobial treatment is not recommended for DFO as for other chronic infections. Surgically or radiologically acquired bone sample for culture is the reference standard recommended by the International Working Group of Diabetic Foot (IWGDF) to diagnose DFO and to determine the causative bacteria and their susceptibility. However, defining appropriate antimicrobial therapy directed to the causative bacteria in DFO is challenging since it requires bone biopsy (BB) procedures which are underused in clinical practice for various reasons: lack of availability, cost, and delay. Some clinicians also find bone biopsy cumbersome or too invasive.
To overcome these barriers, we have set up for a few years a bedside blind BB procedure performed by diabetologists at the bedside in the clinical ward. Since then, this method has been used in more than 200 patients with DFO in the diabetology departments of Lariboisiere Hospital and Bichat Hospital (Paris). We have recently published our observational data of 79 patients showing that bedside BB is a simple, safe and efficient procedure for the diagnosis of DFO with a similar rate of complete healing at 12 months compared to conventional surgical or radiological bone biopsies. In order to extend and confirm these preliminary and observational results, the aim of this study is to compare the efficiency and safety of bedside BB versus conventional bone biopsy in a randomized controlled trial (RCT) of patients with DFO. Our hypothesis is that bedside BB is non-inferior to conventional bone biopsy in DFO and can be used as a simpler alternative procedure to document DFO
Detailed description
During their lifetime, 15 to 25% of patients with diabetes mellitus will develop a Diabetic Foot Ulcer (DFU) related to neuropathy and/or peripheral arterial disease1. DFU is the leading cause of non-traumatic lower-extremity amputation worldwide. DFO, which complicates up to 60% of DFU, is a major trigger of amputation in over 80% of persons with diabetes resulting in subsequent loss of quality of life2. It has been shown that medical treatment of DFO may prevent amputations with early diagnosis of osteomyelitis and appropriate use of antibiotics3. Empirical antimicrobial treatment is not recommended for DFO as for other chronic infections. Surgically or radiologically acquired bone sample for culture is the reference standard recommended by the International Working Group of Diabetic Foot (IWGDF) to diagnose DFO and to determine the causative bacteria and their susceptibility4. However, defining appropriate antimicrobial therapy directed to the causative bacteria in DFO is challenging since it requires bone biopsy (BB) procedures which are underused in clinical practice for various reasons including lack of availability, cost, and delay. Some clinicians also find bone biopsy cumbersome or too invasive.
To overcome these barriers, we have set up for a few years a bedside blind BB procedure performed by a physician at the bedside in the clinical ward. Since then, this method has been used in more than 200 patients with DFO in the diabetology departments of Lariboisiere Hospital and Bichat Hospital (Paris). We have recently published our observational data of 79 patients showing that bedside BB is a simple, safe and efficient procedure for the diagnosis of DFO with a similar rate of complete DFU healing at 12 months compared to conventional surgical or radiological bone biopsies6. In order to extend and confirm these preliminary and observational results, the aim of this study is to compare the efficiency and safety of bedside versus conventional BB in a randomized controlled trial (RCT) of patients with DFO. Our hypothesis is that bedside BB is non inferior to conventional BB in DFO outcomes and can be used as a simpler alternative procedure to document DFO.
The main objective is to demonstrate non-inferiority of beside blind bone biopsy compared to conventional bone biopsy (surgical or radiological) on DFO remission without surgery at 1 year.
The secondary objectives of this study are to:
- compare clinical efficacy between groups of bone biopsy
- compare microbiological culture results between groups
- compare the safety of both procedures
- compare DFO remission according to results of BB (negative or positive)
The health economic of this study are to:
- to estimate total costs for the intervention and total medical costs in each groups
- to estimate total quality adjusted life years (QALYs) based upon EQ5D5L scores
- to calculate the point estimate of the incremental cost utility ratio and estimate the probability of decremental cost effectiveness for the beside blind bone biopsy compared to conventional biopsy.
In this study, we will include subjects with diabetes and DFU with a suspicion of DFO. DFO is a complication of a large amount of DFU and is a major trigger of lower limb amputations. As we will include participants before bacteriological confirmation of DFO through bone biopsy, we will use the clinical and radiological criteria for DFO according to IWGDF 2019 guidelines4.
These criteria include having at least one of the following signs:
- A positive probe to bone test and abnormalities on plain X-ray suggestive for osteomyelitis
- Signs of osteomyelitis on CT-scan and/or MRI and/or white blood cell SPECT/CT and/or 18Fluor-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose-positron emission tomography (FDG-PET)/CT- scan
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bedside blind bone biopsy procedure | Experimental | Procedure: Bedside blind bone biopsy procedureBedside blind bone biopsy procedure performed by a physician of the participating center through healthy skin with bone trocar following local and light systemic anesthesia. Samples will be analyzed for microbiology and histopathology |
| Standard bone biopsy procedure | Active comparator | Procedure: Bedside blind bone biopsy procedureStandard BB procedure (surgical or radiological) performed according to the local standard of care of each participating center and done through healthy skin and under locoregional anesthesia. Samples will be analyzed for microbiology and histopathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged >18 years
- Diabetes mellitus
- At least one of the following signs of osteomyelitis according to IWGDF 2019 guidelines:
- A positive probe to bone test and abnormalities on plain X-ray suggestive for osteomyelitis Signs of osteomyelitis on CT-scan and/or MRI and/or white blood cell SPECT/CT and/or FDG-PET/CT-scan
- Absence of antibacterial therapy within 14 days before inclusion
Key exclusion criteria (12 listed)
- Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- Urgent need for surgery
- Critical limb ischemia which cannot be corrected by revascularization procedure
- Subjects that (are likely to) undergo surgical or percutaneous revascularization are not excluded
- Antibiotic treatment in the last 15 days before bone biopsy
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 |
|---|---|---|
| Bedside blind bone biopsy procedureIt was performed in the patient's room under aseptic conditions. Pain relievers were given orally within the hour preceding the procedure. Superficial anesthesia was performed firstly subcutaneously and then on the periosteum, Inhaled anesthesia was started concomitantly. Following a short incision with a scalpel, the trocar inside a cannula was inserted through healthy skin at a minimum distance of 2 cm from the ulcer edge, close to the bone, preferentially on dorsal foot side. When the trocar was firmly inserted into the bone, it was pulled out from the cannula. Biopsy needle was then slipped into the cannula and twisted into the bone clockwise. Biopsy needle was then pulled out and the bone was pushed out with the ejector pin into a sterile surgical drape and divided in two parts. | Procedure or surgery | Bedside blind bone biopsy procedure, Standard bone biopsy procedure |
Primary outcome
the remission of DFO
Time frame: 12 months
The remission of DFO at 12 months and is defined by a composite criterion as: * an epithelialized ulcer for 28 consecutive days * and absence of local inflammation and/or stabilization or improvement of radiologic abnormalities * and no need for surgery of the foot to treat DFO during follow-up
16 secondary outcomes
Clinical efficacy
Time frame: 12 months
Clinical efficacy
Time frame: 12 months
Clinical efficacy
Time frame: 12 months
Clinical efficacy
Time frame: 12 months
Clinical efficacy
Time frame: 12 months
Clinical efficacy
Time frame: 12 months
Clinical efficacy
Time frame: 12 months
Microbiological results
Time frame: 12 months
Microbiological results
Time frame: 12 months
Microbiological results
Time frame: 12 months
Occurrence of adverse events during the study
Time frame: 12 months
Remission rate of DFO
Time frame: 12 months
costs: Average costs of the biopsies
Time frame: 1 month
costs: Average total 1-year costs
Time frame: 12 months
Average 1 year QALY
Time frame: 12 months
Incremental cost effectiveness ratio
Time frame: 12 months
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 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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.
Louis Potier, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedside blind bone biopsy procedure in people with Subjects With Diabetes and DFU With a Suspicion of DFO, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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: looking for participants now, as of the sponsor's last update on 24 Nov 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 France. 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?
Contact Louis Potier, MD, PhD (01 40 25 88 03, louis.potier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the remission of DFO (time frame: 12 months). 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 24 Nov 2025; AzTrials last refreshed its copy on 1 Nov 2026.