Diabetic Foot UlcerNCT06104969
DFC 004 Biomarkers for Active Diabetic Foot Ulcers
An observational study of Diabetic Foot Ulcer and Diabetic Foot, run by University of Michigan at 9 sites in United States.
Trial summary
This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot, Diabetes
- How many people
- 5,000 participants
- Where
- 9 sitesUnited States
- Study dates
- 15 Jun 2023to 15 Jun 2028
- Phase
- Observational
- 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
Study population: Adults with diabetes with at least one open diabetic foot ulcer.
Who may be able to join
- Provision of signed and dated informed consent form.
- Age 18 years or older.
- Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. [ADA Standards of Clinical Care Diabetes Care 2022, Suppl 1]
- Open foot ulcer, defined as an open wound from malleolus down. This includes post-surgical wounds within this area left open to heal by secondary intention. In case of multiple ulcers, the largest ulcer will be considered the study index DFU.
- Agreement to adhere to protocol visits and provide all required biospecimens and clinical data.
Who cannot join
- Participation in an interventional clinical trial for DFU within 1 month of Visit 1.
- Currently receiving radiation to target area or chemotherapy.
- Gangrene in any portion of the foot with the index ulcer.
- Planned revascularization or under evaluation for revascularization of the index limb for advanced ischemia within next 4 weeks of Week 0.
- Severe limb ischemia (SVS WIfl Ischemia grade 3).
- Any concomitant medical or psychiatric condition that, in the opinion of the investigator(s), would compromise the participant's ability to safely complete the study.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Kourtney Noll, 734-763-0177, kneibaue@med.umich.edu
Crystal Holmes, DPM
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30303
Nazanin Soleimanmanesh, 404-251-2599, nazanin.soleimanmanesh@emory.edu
Marcos Schechter
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Aristidis Veves, 617-632-7075, aveves@bidmc.harvard.edu
Aristidis Veves, MD
- Recruiting
Northwell Health
Lake Success, New York, 11042
Amit Rao, 516-233-3671, ARAO3@NORTHWELL.EDU
Alisha Oropallo, MD
- Suspended
University of Southern California
Los Angeles, California, 90033
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Shomita Steiner, 463-237-8770, SSTEINER@pitt.edu
Chanden Sen, PhD
- Recruiting
University of Texas Health San Antonio
San Antonio, Texas, 78229
Lawrence Lavery, 210-567-7000, lavery@uthscsa.edu
Lawrence Lavery
- Recruiting
University of California - San Francisco
San Francisco, California, 94143
Claudio Gamboa, 415-353-4379, claudio.gamboa@ucsf.edu
Michael Conte, MD
- Recruiting
University of Arizona College of Medicine
Tucson, Arizona, 85724
Fleur Maturo, 520-621-8296, fleurmartinez@arizona.edu
Geoffrey Gurtner, MD
About this study
Official title: Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers: Open Wound Master Study
This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions
Read the detailed description
This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions The platform study is designed to be flexible so that it is suitable for a wide range of studies relevant to patients with open (active) DFUs.
This platform study will enroll patients with DFUs seen in an outpatient setting in diabetic foot and wound care clinics across a range of healthcare systems, including community settings and tertiary care hospitals, participating in the DFC.
The platform study will include common procedures that are applicable across the entire spectrum of DFUs (e.g., uniform biospecimen collections, clinical and usual care characteristics, social determinants of health, and patient reported outcomes). Blood, wound fluid (by a variety of methods), wound dressings, and debridement tissue (if debridement is performed during the participant's clinical wound care) will be collected from all participants to support a biorepository for concurrent and future research. Urine samples will be collected if participants agree to provide them, and collection will be encouraged. Biomarker-specific studies requiring additional data or biospecimens not required in the platform study will be included as appendices, as needed. Other biomarker-specific studies that use platform study biospecimens and study data will follow the DFC ancillary study process.
Eligible participants enrolled in the master protocol who signed the informed consent may be enrolled in multiple biomarkers sub studies associated with the master protocol without the need to sign an additional informed consent.
This platform study is non-interventional; no study prescribed agents or therapies are administered.
Eligible and consented participants are managed at each DFC site according to the usual clinical care, which is expected to be in line with the current standards of care recommendations1-3. The study will collect relevant details regarding the care provided at each clinic visit and participant outcomes.
Follow-up for participants will vary based upon the occurrence and timing of healing:
- All participants will be followed every other week for one month and monthly thereafter until the wound is healed or week 52 if the wound has not healed.
- Participants who experience wound healing prior to week 52 will have a confirmation visit 2 weeks later. These participants will also be assessed for recurrence of their DFU at weeks 52 and 78 via phone call or video visit.
- Participants who experience wound healing at week 52 will have a confirmation visit 2 weeks later. These participants will also be assessed for recurrence of their DFU at week 78 via phone call or video visit.
- Participants who do not experience wound healing by week 52 will have an additional phone call or video visit scheduled at week 78 to assess patient-reported wound healing, infection, or amputation with confirmation by electronic medical records (EMR), if available.
Study visits may occur in conjunction with the participant's scheduled clinical follow-up visits. After wound healing has been confirmed, the visit may be conducted by remote means.
The master protocol will enable evaluation of the time to healing over a 78-week period and of expectations on the natural history of wound healing in contemporary DFU participants. It also enables exploring rates of DFU recurrence in those who healed. These data will lead to more accurate DFU-specific standards of care guidelines that will have a direct impact and benefit in the clinical care, for a personalized approach.
General and biomarker-specific analyses will be performed. Participants who share common demographic or clinical characteristics may be pooled across substudies.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Diabetes
- Keywords
- diabetic foot ulcer, Diabetic Foot Consortium
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Foot Ulcer | Adult individuals with at least one diabetic foot ulcer who meet inclusion/exclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
Proportion of participants with complete wound healing by week 52, defined as complete wound closure where there is skin re-epithelialization without drainage or dressing requirements at two consecutive study visits 2 weeks apart.
Measured: 52 Weeks
DFU Infections
Proportion of participants who develop infections of the index DFU among those with no infections at baseline.
Measured: 52 Weeks
Amputations
Proportion of participants who have an amputation of the limb associated with the index DFU.
Measured: 52 Weeks
Prediction Performance
Measures of prediction performance (e.g., predictive power, AUC, ROC, Akaike information criterion) of biomarker(s) for each of the clinical outcomes: Wound Healing, DFU Infections, and Amputations described above.
Prediction performance is measured by multiple statistical measures to assess ability of the biomarker to predict event risk for each of the three clinical outcomes.
Measured: 52 Weeks
Biospecimens Count
Proportion of eligible participants providing biospecimens by site, and by type (serum, plasma, wound fluid, wound dressings, wound debridement tissue, urine).
Measured: 52 Weeks
Biospecimen Quality
Proportion of biospecimens of adequate quality by type.
Measured: 52 Weeks
Standard of Care Prescription by Site
Proportion of sites that prescribe the most current SOC into usual care, specifically for: (a) offloading; (b) vascular assessment; and (c) debridement.
Measured: 52 Weeks
Standard of Care Adherence
Proportion of participants who adhere to physician-prescribed SOC therapies for their DFU care.
Measured: 52 Weeks
Secondary outcomes (10)
Time to Healing
Time to healing, defined as the time (in weeks) from baseline to complete healing.
Measured: Up to 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in SF-12 Physical Domain Score
Change from baseline to later of Week 52 or Confirmation Visit in:
SF-12 physical domain score.
SF-12 for physical
- Score range from 0-100
- Higher scores indicate better physical health.
Measured: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in SF-12 Mental Domain Score
Change from baseline to later of Week 52 or Confirmation Visit in:
SF-12 mental domain score.
- Score range from 0-100
- Higher scores indicate better mental health.
Measured: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF subscale leisure score.
Change from baseline to later of Week 52 or Confirmation Visit in:
DFS-SF subscale scores (leisure, physical health, dependence/daily life, negative emotions, worried about ulcers/feet, bother by ulcer care).
DFS-SF subscale scoring
- Five-point scale: 1=never to 5=all the time
- Score is based on sum of all items
- Scored 0-100 - higher scores indicate better QOL
Measured: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF physical health subscale score.
Change from baseline to later of Week 52 or Confirmation Visit in:
DFS-SF subscale scores (leisure, physical health, dependence/daily life, negative emotions, worried about ulcers/feet, bother by ulcer care).
DFS-SF subscale scoring
- Five-point scale: 1=never to 5=all the time
- Score is based on sum of all items
- Scored 0-100 - higher scores indicate better QOL
Measured: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF dependence/daily life subscale score.
Change from baseline to later of Week 52 or Confirmation Visit in:
DFS-SF subscale scores (leisure, physical health, dependence/daily life, negative emotions, worried about ulcers/feet, bother by ulcer care).
DFS-SF subscale scoring
- Five-point scale: 1=never to 5=all the time
- Score is based on sum of all items
- Scored 0-100 - higher scores indicate better QOL
Measured: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF negative emotions subscale score.
Change from baseline to later of Week 52 or Confirmation Visit in:
DFS-SF subscale scores (leisure, physical health, dependence/daily life, negative emotions, worried about ulcers/feet, bother by ulcer care).
DFS-SF subscale scoring
- Five-point scale: 1=never to 5=all the time
- Score is based on sum of all items
- Scored 0-100 - higher scores indicate better QOL
Measured: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF worried about ulcers/feet subscale score
Change from baseline to later of Week 52 or Confirmation Visit in:
DFS-SF subscale scores (leisure, physical health, dependence/daily life, negative emotions, worried about ulcers/feet, bother by ulcer care).
DFS-SF subscale scoring
- Five-point scale: 1=never to 5=all the time
- Score is based on sum of all items
- Scored 0-100 - higher scores indicate better QOL
Measured: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF bother by ulcer care subscale score.
Change from baseline to later of Week 52 or Confirmation Visit in:
DFS-SF subscale scores (leisure, physical health, dependence/daily life, negative emotions, worried about ulcers/feet, bother by ulcer care).
DFS-SF subscale scoring
- Five-point scale: 1=never to 5=all the time
- Score is based on sum of all items
- Scored 0-100 - higher scores indicate better QOL
Measured: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in PROMIS Sleep Disturbance
Change from baseline to later of Week 52 or Confirmation Visit in:
PROMIS Sleep disturbance.
- Each items has a 5-point response scale
- 1=never, 2=rarely, 3=sometimes, 4=often, 5=always
- Score ranges from 8-40; higher scores indicate greater severity of sleep disturbance.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start15 Jun 2023
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathie Spino, ScD, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104969
- Sponsor's protocol ID
- HUM00231478
- Status last verified
- Sep 2026
- First submitted
- 19 Jul 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive and Diagnostic Biomarkers for Diabetic Foot Ulcers: Open Wound Master Study
- ClinicalTrials.gov ID
- NCT06104969
- Acronym / sponsor ID
- HUM00231478
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Diabetes
- Keywords
- diabetic foot ulcer, Diabetic Foot Consortium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 27 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.
This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions
Detailed description
This study is a platform study designed to efficiently test multiple biomarkers to identify diabetic foot ulcers (DFUs) with a higher potential for healing versus not healing that ultimately could be applied at the point of care to drive personalized management decisions, and to better inform clinical trials of wound healing interventions The platform study is designed to be flexible so that it is suitable for a wide range of studies relevant to patients with open (active) DFUs.
This platform study will enroll patients with DFUs seen in an outpatient setting in diabetic foot and wound care clinics across a range of healthcare systems, including community settings and tertiary care hospitals, participating in the DFC.
The platform study will include common procedures that are applicable across the entire spectrum of DFUs (e.g., uniform biospecimen collections, clinical and usual care characteristics, social determinants of health, and patient reported outcomes). Blood, wound fluid (by a variety of methods), wound dressings, and debridement tissue (if debridement is performed during the participant's clinical wound care) will be collected from all participants to support a biorepository for concurrent and future research. Urine samples will be collected if participants agree to provide them, and collection will be encouraged. Biomarker-specific studies requiring additional data or biospecimens not required in the platform study will be included as appendices, as needed. Other biomarker-specific studies that use platform study biospecimens and study data will follow the DFC ancillary study process.
Eligible participants enrolled in the master protocol who signed the informed consent may be enrolled in multiple biomarkers sub studies associated with the master protocol without the need to sign an additional informed consent.
This platform study is non-interventional; no study prescribed agents or therapies are administered.
Eligible and consented participants are managed at each DFC site according to the usual clinical care, which is expected to be in line with the current standards of care recommendations1-3. The study will collect relevant details regarding the care provided at each clinic visit and participant outcomes.
Follow-up for participants will vary based upon the occurrence and timing of healing:
- All participants will be followed every other week for one month and monthly thereafter until the wound is healed or week 52 if the wound has not healed.
- Participants who experience wound healing prior to week 52 will have a confirmation visit 2 weeks later. These participants will also be assessed for recurrence of their DFU at weeks 52 and 78 via phone call or video visit.
- Participants who experience wound healing at week 52 will have a confirmation visit 2 weeks later. These participants will also be assessed for recurrence of their DFU at week 78 via phone call or video visit.
- Participants who do not experience wound healing by week 52 will have an additional phone call or video visit scheduled at week 78 to assess patient-reported wound healing, infection, or amputation with confirmation by electronic medical records (EMR), if available.
Study visits may occur in conjunction with the participant's scheduled clinical follow-up visits. After wound healing has been confirmed, the visit may be conducted by remote means.
The master protocol will enable evaluation of the time to healing over a 78-week period and of expectations on the natural history of wound healing in contemporary DFU participants. It also enables exploring rates of DFU recurrence in those who healed. These data will lead to more accurate DFU-specific standards of care guidelines that will have a direct impact and benefit in the clinical care, for a personalized approach.
General and biomarker-specific analyses will be performed. Participants who share common demographic or clinical characteristics may be pooled across substudies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic Foot Ulcer | – | –Adult individuals with at least one diabetic foot ulcer who meet inclusion/exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with diabetes with at least one open diabetic foot ulcer.
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form.
- Age 18 years or older.
- Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria. [ADA Standards of Clinical Care Diabetes Care 2022, Suppl 1]
- Open foot ulcer, defined as an open wound from malleolus down. This includes post-surgical wounds within this area left open to heal by secondary intention. In case of multiple ulcers, the largest ulcer will be considered the study index DFU.
- Agreement to adhere to protocol visits and provide all required biospecimens and clinical data.
Key exclusion criteria (6 listed)
- Participation in an interventional clinical trial for DFU within 1 month of Visit 1.
- Currently receiving radiation to target area or chemotherapy.
- Gangrene in any portion of the foot with the index ulcer.
- Planned revascularization or under evaluation for revascularization of the index limb for advanced ischemia within next 4 weeks of Week 0.
- Severe limb ischemia (SVS WIfl Ischemia grade 3).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wound Healing
Time frame: 52 Weeks
Proportion of participants with complete wound healing by week 52, defined as complete wound closure where there is skin re-epithelialization without drainage or dressing requirements at two consecutive study visits 2 weeks apart.
DFU Infections
Time frame: 52 Weeks
Proportion of participants who develop infections of the index DFU among those with no infections at baseline.
Amputations
Time frame: 52 Weeks
Proportion of participants who have an amputation of the limb associated with the index DFU.
Prediction Performance
Time frame: 52 Weeks
Measures of prediction performance (e.g., predictive power, AUC, ROC, Akaike information criterion) of biomarker(s) for each of the clinical outcomes: Wound Healing, DFU Infections, and Amputations described above. Prediction performance is measured by multiple statistical measures to assess ability of the biomarker to predict event risk for each of the three clinical outcomes.
Biospecimens Count
Time frame: 52 Weeks
Proportion of eligible participants providing biospecimens by site, and by type (serum, plasma, wound fluid, wound dressings, wound debridement tissue, urine).
Biospecimen Quality
Time frame: 52 Weeks
Proportion of biospecimens of adequate quality by type.
Standard of Care Prescription by Site
Time frame: 52 Weeks
Proportion of sites that prescribe the most current SOC into usual care, specifically for: (a) offloading; (b) vascular assessment; and (c) debridement.
Standard of Care Adherence
Time frame: 52 Weeks
Proportion of participants who adhere to physician-prescribed SOC therapies for their DFU care.
10 secondary outcomes
Time to Healing
Time frame: Up to 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in SF-12 Physical Domain Score
Time frame: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in SF-12 Mental Domain Score
Time frame: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF subscale leisure score.
Time frame: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF physical health subscale score.
Time frame: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF dependence/daily life subscale score.
Time frame: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF negative emotions subscale score.
Time frame: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF worried about ulcers/feet subscale score
Time frame: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in DFS-SF bother by ulcer care subscale score.
Time frame: 52 Weeks
Change from baseline to later of Week 52 or Confirmation Visit in PROMIS Sleep Disturbance
Time frame: 52 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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
University of California - San Francisco
San Francisco, United States
Emory University School of Medicine
Atlanta, United States
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer and Diabetic Foot, run by University of Michigan at 9 sites 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 5 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing (time frame: 52 Weeks). The study lists 8 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 9 Sep 2026.