Diabetic Peripheral NeuropathyNCT04720170
Exploratory Study of the Efficacy of Standard of Care Revascularization of the Lower Extremity
A study testing Revascularization in people with Diabetic Peripheral Neuropathy, run by Diabetes and Glandular Disease Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of the standard of care revascularization of the lower extremity with the addition of revascularization of the lateral plantar artery and anterior pedal loop of the foot as treatment for diabetic peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 30 to 80 years (inclusive at first screening visit)
- Clinical diagnosis of type 1 or type 2 diabetes as diagnosed by HbA1c ≥ 6.5% or current treatment
- Clinical signs and symptoms of diabetic peripheral neuropathy bilaterally affecting the lower extremities, in the investigator's opinion, which may include neuropathic symptoms (e.g., numbness, tingling, burning sensation, sharp pains, sensitivity to touch) and decreased distal sensation (e.g., decreased vibration, pinprick or pain sensation, monofilament)
- HbA1c ≤ 11% (historical results allowed if performed within the past 90 days)
- Females of child-bearing potential who are willing to use contraceptive measures to prevent pregnancy for the duration of the study
- Willing to attend all scheduled study visits and undergo all study procedures
Show all 9Show fewer
- Clinical diagnosis of Peripheral Artery Disease (PAD)
- Be able to understand, speak, read and write English
- Have medical insurance or financial means to cover the cost of the revascularization procedure and follow-up visits with the Interventional Radiologist
Who cannot join
- Inability to undergo angiogram with revascularization
- Unilateral neuropathic findings or symptoms
- Vitamin B-12 level < 400 pg/ml (historical results allowed if performed within the past 30 days) *
- Known causes of peripheral neuropathy other than diabetes, e.g., Amyloidosis, Tangier disease, Fabry's disease, hereditary sensory autonomic neuropathy, alcohol-related neuropathy, drug-induced neuropathy (e.g., chemotherapy, antibiotics, anti-retroviral agents, other neurotoxic agents) hypothyroidism that is not well controlled, rheumatoid arthritis or autoimmune disorders requiring treatment with corticosteroids, anti-tumor necrosis factor or immune-modulating medicines
- Known history of Hepatitis B, C, or HIV
- Lower limb amputation, including toe
Show all 21Show fewer
- Lower extremity inoperable occlusive vascular disease
- Inability to provide informed consent
- History of bleeding disorders
- History of diabetic ulcers to the lower extremities
- History of any surgical bypass of the lower extremities prior to randomization
- History of previous revascularization of the lower extremities prior to randomization
- End Stage Renal Disease (ESRD) requiring or on dialysis
- Thyroid Stimulating Hormone -TSH >10.0 uu/mL*
- Potassium > 5.5 mmol/L. *
- Calcium < 8.5 mg/dL or > 11mg/dL *
- Hemoglobin < 9.0 g/dL *
- Female that is pregnant, breastfeeding or intends to become pregnant during the study period
- Clinically significant abnormal ECG findings, in the opinion of the Investigator
- Participation in another clinical trial with investigational drug or device at time of screening
- Any other clinically significant disorders or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with the protocol requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes and Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
About this study
Official title: Revascularization of the Lateral Plantar Artery and Anterior Pedal Loop of the Foot as Treatment for Diabetic Peripheral Neuropathy.
The purpose of this study is to evaluate the efficacy of the standard of care revascularization of the lower extremity with the addition of revascularization of the lateral plantar artery and anterior pedal loop of the foot as treatment for diabetic peripheral neuropathy.
Read the detailed description
This is a 26 week, single arm, single-site, Investigator-initiated, exploratory trial evaluating the efficacy of the standard of care revascularization of the lower extremity with the addition of revascularization of the lateral plantar artery and anterior pedal loop of the foot as treatment for participants with PAD, diabetic neuropathy and have a clinical diagnosis of type 1 or type 2 diabetes whose main symptoms are numbness and/or tingling of the feet with or without pain.
Participants who satisfy eligibility criteria may undergo standard of care revascularization of one lower extremity as required, with the addition of revascularization of the lateral plantar artery and anterior pedal loop followed by a 26-week follow-up phase. Standard of Care revascularization will be performed in any limb with ≥ 50% stenosis as determined by intra-vascular ultrasound (IVUS) at the time of planned study intervention.
Participants will be evaluated prior to intervention and at 2, 4, 14 and 26 weeks after the pedal loop intervention.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Revascularization
- Keywords
- Diabetes, Type 1 Diabetes, Type 2 Diabetes, Neuropathy, Diabetic Peripheral Neuropathy, Peripheral Artery Disease, PAD
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevascularizationProcedure or surgery
Angiogram and IVUS with revascularization of the lateral plantar artery and pedal arch on target foot.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | This is a 26 week, single arm, single-site, Investigator-initiated, exploratory trial evaluating the efficacy of the standard of care revascularization of the lower extremity with the addition of revascularization of the lateral plantar artery and anterior pedal loop of the foot as treatment for participants with PAD, diabetic neuropathy and have a clinical diagnosis of type 1 or type 2 diabetes whose main symptoms are numbness and/or tingling of the feet with or without pain. Receives: Procedure: Revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-epidermal Nerve Fiber Density
Change from baseline in intra-epidermal nerve fiber density (IENFD) via skin biopsy of the revascularized foot over the extensor digitorum brevis muscle (EDBM) at week 26.
Measured: 26 weeks
Secondary outcomes (7)
Intra-epidermal Nerve Fiber Density
Number and percent of participants whose IENFD have increased by at least 20% from baseline
Measured: 14 and 26 weeks
Utah Early Neuropathy Scale
Number and percentage of participants with improvement on Utah Neuropathy Scale (UENS)
Measured: 14 and 26 weeks
Sural Nerve Action Potential Amplitude
Number and percentage of participants with improvement of sural nerve action potential amplitude
Measured: 14 and 26 weeks
Sudoscan
Number and percentage of participants with 20% improvement on Sudoscan
Measured: 14 and 26 weeks
Intra-epidermal Nerve Fiber Density
Number and percentage of participants with improvement of intra-epidermal nerve fiber density
Measured: 14 weeks
Neuropathic Pain Syndrome Inventory
Improvement in quality of life as measured by the Neuropathic Pain Syndrome Inventory
Measured: 14 and 26 weeks
Patency of Lateral Plantar Artery
Number and percentage of participants with patency of lateral plantar artery per ultrasound
Measured: 14 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start15 Feb 2021 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 26 week, single arm, single site
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes and Glandular Disease Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Modern Vascular, LLC
- Responsible party
- Sponsor
- Investigators
- Dallas Broadway, MD, Principal investigator, Modern Vascular, LLCMark S Kipnes, MD, Principal investigator, Diabetes and Glandular Disease Clinic, P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720170
- Sponsor's protocol ID
- DBMK-001
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and Informed Consent
Publications
Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.
PubMed 15030944Cameron NE, Eaton SE, Cotter MA, Tesfaye S. Vascular factors and metabolic interactions in the pathogenesis of diabetic neuropathy. Diabetologia. 2001 Nov;44(11):1973-88. doi: 10.1007/s001250100001.
PubMed 11719828Ibrahim S, Harris ND, Radatz M, Selmi F, Rajbhandari S, Brady L, Jakubowski J, Ward JD. A new minimally invasive technique to show nerve ischaemia in diabetic neuropathy. Diabetologia. 1999 Jun;42(6):737-42. doi: 10.1007/s001250051222.
PubMed 10382594Malik RA, Masson EA, Sharma AK, Lye RH, Ah-See AK, Compton AM, Tomlinson DR, Hanley SP, Boulton AJ. Hypoxic neuropathy: relevance to human diabetic neuropathy. Diabetologia. 1990 May;33(5):311-8. doi: 10.1007/BF00403326.
PubMed 2376302Newrick PG, Wilson AJ, Jakubowski J, Boulton AJ, Ward JD. Sural nerve oxygen tension in diabetes. Br Med J (Clin Res Ed). 1986 Oct 25;293(6554):1053-4. doi: 10.1136/bmj.293.6554.1053.
PubMed 3094772Ram Z, Sadeh M, Walden R, Adar R. Vascular insufficiency quantitatively aggravates diabetic neuropathy. Arch Neurol. 1991 Dec;48(12):1239-42. doi: 10.1001/archneur.1991.00530240043016.
PubMed 1845025Singleton JR, Bixby B, Russell JW, Feldman EL, Peltier A, Goldstein J, Howard J, Smith AG. The Utah Early Neuropathy Scale: a sensitive clinical scale for early sensory predominant neuropathy. J Peripher Nerv Syst. 2008 Sep;13(3):218-27. doi: 10.1111/j.1529-8027.2008.00180.x.
PubMed 18844788Tesfaye S, Harris N, Jakubowski JJ, Mody C, Wilson RM, Rennie IG, Ward JD. Impaired blood flow and arterio-venous shunting in human diabetic neuropathy: a novel technique of nerve photography and fluorescein angiography. Diabetologia. 1993 Dec;36(12):1266-74. doi: 10.1007/BF00400804.
PubMed 8307254Veves A, Donaghue VM, Sarnow MR, Giurini JM, Campbell DR, LoGerfo FW. The impact of reversal of hypoxia by revascularization on the peripheral nerve function of diabetic patients. Diabetologia. 1996 Mar;39(3):344-8. doi: 10.1007/BF00418351.
PubMed 8721781Young MJ, Veves A, Walker MG, Boulton AJ. Correlations between nerve function and tissue oxygenation in diabetic patients: further clues to the aetiology of diabetic neuropathy? Diabetologia. 1992 Dec;35(12):1146-50. doi: 10.1007/BF00401368.
PubMed 1478366Young MJ, Veves A, Smith JV, Walker MG, Boulton AJ. Restoring lower limb blood flow improves conduction velocity in diabetic patients. Diabetologia. 1995 Sep;38(9):1051-4. doi: 10.1007/BF00402174.
PubMed 8591818
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularization of the Lateral Plantar Artery and Anterior Pedal Loop of the Foot as Treatment for Diabetic Peripheral Neuropathy.
- ClinicalTrials.gov ID
- NCT04720170
- Acronym / sponsor ID
- DBMK-001
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetes, Type 1 Diabetes, Type 2 Diabetes, Neuropathy, Diabetic Peripheral Neuropathy, Peripheral Artery Disease, PAD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Diabetes and Glandular Disease ClinicIndustry (pharma, biotech, devices)
- Collaborators
- Modern Vascular, LLC
- Study start
- 15 Feb 2021 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 22 Jan 2021 (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 purpose of this study is to evaluate the efficacy of the standard of care revascularization of the lower extremity with the addition of revascularization of the lateral plantar artery and anterior pedal loop of the foot as treatment for diabetic peripheral neuropathy.
Detailed description
This is a 26 week, single arm, single-site, Investigator-initiated, exploratory trial evaluating the efficacy of the standard of care revascularization of the lower extremity with the addition of revascularization of the lateral plantar artery and anterior pedal loop of the foot as treatment for participants with PAD, diabetic neuropathy and have a clinical diagnosis of type 1 or type 2 diabetes whose main symptoms are numbness and/or tingling of the feet with or without pain.
Participants who satisfy eligibility criteria may undergo standard of care revascularization of one lower extremity as required, with the addition of revascularization of the lateral plantar artery and anterior pedal loop followed by a 26-week follow-up phase. Standard of Care revascularization will be performed in any limb with ≥ 50% stenosis as determined by intra-vascular ultrasound (IVUS) at the time of planned study intervention.
Participants will be evaluated prior to intervention and at 2, 4, 14 and 26 weeks after the pedal loop intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 26 week, single arm, single site
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Procedure: RevascularizationThis is a 26 week, single arm, single-site, Investigator-initiated, exploratory trial evaluating the efficacy of the standard of care revascularization of the lower extremity with the addition of revascularization of the lateral plantar artery and anterior pedal loop of the foot as treatment for participants with PAD, diabetic neuropathy and have a clinical diagnosis of type 1 or type 2 diabetes whose main symptoms are numbness and/or tingling of the feet with or without pain. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female age 30 to 80 years (inclusive at first screening visit)
- Clinical diagnosis of type 1 or type 2 diabetes as diagnosed by HbA1c ≥ 6.5% or current treatment
- Clinical signs and symptoms of diabetic peripheral neuropathy bilaterally affecting the lower extremities, in the investigator's opinion, which may include neuropathic symptoms (e.g., numbness, tingling, burning sensation, sharp pains, sensitivity to touch) and decreased distal sensation (e.g., decreased vibration, pinprick or pain sensation, monofilament)
- HbA1c ≤ 11% (historical results allowed if performed within the past 90 days)
- Females of child-bearing potential who are willing to use contraceptive measures to prevent pregnancy for the duration of the study
Key exclusion criteria (21 listed)
- Inability to undergo angiogram with revascularization
- Unilateral neuropathic findings or symptoms
- Vitamin B-12 level < 400 pg/ml (historical results allowed if performed within the past 30 days) *
- Known causes of peripheral neuropathy other than diabetes, e.g., Amyloidosis, Tangier disease, Fabry's disease, hereditary sensory autonomic neuropathy, alcohol-related neuropathy, drug-induced neuropathy (e.g., chemotherapy, antibiotics, anti-retroviral agents, other neurotoxic agents) hypothyroidism that is not well controlled, rheumatoid arthritis or autoimmune disorders requiring treatment with corticosteroids, anti-tumor necrosis factor or immune-modulating medicines
- Known history of Hepatitis B, C, or HIV
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 |
|---|---|---|
| RevascularizationAngiogram and IVUS with revascularization of the lateral plantar artery and pedal arch on target foot. | Procedure or surgery | Single Arm |
Primary outcome
Intra-epidermal Nerve Fiber Density
Time frame: 26 weeks
Change from baseline in intra-epidermal nerve fiber density (IENFD) via skin biopsy of the revascularized foot over the extensor digitorum brevis muscle (EDBM) at week 26.
7 secondary outcomes
Intra-epidermal Nerve Fiber Density
Time frame: 14 and 26 weeks
Utah Early Neuropathy Scale
Time frame: 14 and 26 weeks
Sural Nerve Action Potential Amplitude
Time frame: 14 and 26 weeks
Sudoscan
Time frame: 14 and 26 weeks
Intra-epidermal Nerve Fiber Density
Time frame: 14 weeks
Neuropathic Pain Syndrome Inventory
Time frame: 14 and 26 weeks
Patency of Lateral Plantar Artery
Time frame: 14 and 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Results publication: PubMed 15030944Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.
- Results publication: PubMed 11719828Cameron NE, Eaton SE, Cotter MA, Tesfaye S. Vascular factors and metabolic interactions in the pathogenesis of diabetic neuropathy. Diabetologia. 2001 Nov;44(11):1973-88. doi: 10.1007/s001250100001.
- Results publication: PubMed 10382594Ibrahim S, Harris ND, Radatz M, Selmi F, Rajbhandari S, Brady L, Jakubowski J, Ward JD. A new minimally invasive technique to show nerve ischaemia in diabetic neuropathy. Diabetologia. 1999 Jun;42(6):737-42. doi: 10.1007/s001250051222.
- Results publication: PubMed 2376302Malik RA, Masson EA, Sharma AK, Lye RH, Ah-See AK, Compton AM, Tomlinson DR, Hanley SP, Boulton AJ. Hypoxic neuropathy: relevance to human diabetic neuropathy. Diabetologia. 1990 May;33(5):311-8. doi: 10.1007/BF00403326.
- Results publication: PubMed 3094772Newrick PG, Wilson AJ, Jakubowski J, Boulton AJ, Ward JD. Sural nerve oxygen tension in diabetes. Br Med J (Clin Res Ed). 1986 Oct 25;293(6554):1053-4. doi: 10.1136/bmj.293.6554.1053.
- Results publication: PubMed 1845025Ram Z, Sadeh M, Walden R, Adar R. Vascular insufficiency quantitatively aggravates diabetic neuropathy. Arch Neurol. 1991 Dec;48(12):1239-42. doi: 10.1001/archneur.1991.00530240043016.
- Results publication: PubMed 18844788Singleton JR, Bixby B, Russell JW, Feldman EL, Peltier A, Goldstein J, Howard J, Smith AG. The Utah Early Neuropathy Scale: a sensitive clinical scale for early sensory predominant neuropathy. J Peripher Nerv Syst. 2008 Sep;13(3):218-27. doi: 10.1111/j.1529-8027.2008.00180.x.
- Results publication: PubMed 8307254Tesfaye S, Harris N, Jakubowski JJ, Mody C, Wilson RM, Rennie IG, Ward JD. Impaired blood flow and arterio-venous shunting in human diabetic neuropathy: a novel technique of nerve photography and fluorescein angiography. Diabetologia. 1993 Dec;36(12):1266-74. doi: 10.1007/BF00400804.
- Results publication: PubMed 8721781Veves A, Donaghue VM, Sarnow MR, Giurini JM, Campbell DR, LoGerfo FW. The impact of reversal of hypoxia by revascularization on the peripheral nerve function of diabetic patients. Diabetologia. 1996 Mar;39(3):344-8. doi: 10.1007/BF00418351.
- Results publication: PubMed 1478366Young MJ, Veves A, Walker MG, Boulton AJ. Correlations between nerve function and tissue oxygenation in diabetic patients: further clues to the aetiology of diabetic neuropathy? Diabetologia. 1992 Dec;35(12):1146-50. doi: 10.1007/BF00401368.
- Results publication: PubMed 8591818Young MJ, Veves A, Smith JV, Walker MG, Boulton AJ. Restoring lower limb blood flow improves conduction velocity in diabetic patients. Diabetologia. 1995 Sep;38(9):1051-4. doi: 10.1007/BF00402174.
- PubMed ID:11719828Link provided by the sponsor.
- PubMed ID:10382594Link provided by the sponsor.
- PubMed ID:2376302Link provided by the sponsor.
- PubMed ID:3094772Link provided by the sponsor.
- PubMed ID:8307254Link provided by the sponsor.
- PubMed ID:8721781Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study protocol and Informed Consent
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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.
Dallas Broadway, MD principal investigator
Modern Vascular, LLC
Mark S Kipnes, MD principal investigator
Diabetes and Glandular Disease Clinic, P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revascularization in people with Diabetic Peripheral Neuropathy, run by Diabetes and Glandular Disease Clinic at 1 site in United States.
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 9 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 22 Jan 2021. 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Terri L Ryan, RN (210-614-8612 ext. 1630, terri.ryan@dgdclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-epidermal Nerve Fiber Density (time frame: 26 weeks). 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 NCT04720170, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.