Diabetic FootWOUNDJOURNEYNCT02280733
A Real-World Registry of Chronic Wounds and Ulcers
An observational study of Diabetic Foot and Pressure Ulcer, run by U.S. Wound Registry at 1 site in United States.
Trial summary
WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence
- How many people
- 300,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2005to Jan 2030
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic wounds or ulcers treated at participating sites in any US State and Puerto Rico. All patients and wounds are included without sampling. Each wound can be analyzed independently, even when multiple wounds exist on a single patient. Sampling Method: Non-Probability Sample Minimum Age: 0 Years Maximum Age: None (patients aged 90+ are reported in aggregate per HIPAA) Sex: All Gender Based: No Accepts Healthy Volunteers: No
Who may be able to join
- Presence of one or more chronic wounds or ulcers of any etiology
- Wound or ulcer must be treated at a participating site (which can be a hospital outpatient department, office, mobile practitioner, in the home setting, skilled nursing, etc.)
- Care must be documented using the purpose-built, wound-specific structured electronic health record (EHR) or electronic data capture (EDC) system
- All ages, including infants and patients aged 90 years or older (reported in aggregate in accordance with HIPAA de-identification standards)
- All sexes and gender identities
- All wound types and severities, including multiple wounds per patient
Who cannot join
- -None (the registry includes all eligible patients treated at participating sites without sampling or exclusion criteria)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
US Wound Registry
The Woodlands, Texas, 77386
Caroline E Fife, MD, 800-603-7896, cfife@intellicure.com
About this study
Official title: A Longitudinal, Real World, Observational Registry of Chronic Wounds and Ulcers and the Patients Who Have Them
WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.
Read the detailed description
WOUNDJOURNEY is a longitudinal, real-world observational registry focused on the chronic disease burden and patient journey of individuals with chronic wounds and ulcers. Data collection began in 2005 and continues prospectively, capturing structured clinical data at the point of care using a purpose-built certified EHR or EDC system. These data are securely transmitted to the U.S. Wound Registry (USWR), a CMS-designated Qualified Clinical Data Registry (QCDR).
All major wound types are represented: Diabetic foot ulcers (DFUs), diabetic ulcers not on the foot, Venous leg ulcers (VLUs), Arterial ulcers, Pressure ulcers/injuries, Surgical complications, Traumatic wounds, Vasculitic/inflammatory, and sickle cell-related ulcers, and chronic non-pressure ulcers.
The registry collects detailed data on standard-of-care practices and advanced wound care interventions, including brand-specific information on: Advanced dressings (e.g., collagen, antimicrobial), Compression therapy, Offloading devices, Cellular and/or tissue-based products (CTPs) also called Cellular, Acellular, or Matrix-like Products (CAMPs) or "skin substitutes," Negative pressure wound therapy, MIST therapy (low-frequency ultrasound), Topical oxygen therapy (TOT), Hyperbaric Oxygen Therapy (HBOT), Topical growth factors (e.g., Becaplermin), Enzymatic and mechanical debridement, Fluorescent imaging for bacterial load, Topical antibiotics and antimicrobials, and other treatments.
The registry captures key elements of the patient journey, including: Frequency of debridement, Sites of care, number of patient visits and number of wound visits, Dressing changes, Use and timing of advanced therapies, Comorbid disease burden and clinical complexity, Patient Frailty, number of wounds and ulcers per patient, patient time in service, wound time service, patient and wound outcomes, the development of new wounds while in service and complication rates.
Wounds are risk stratified using the Wound Healing Index, enabling case-mix adjustment and longitudinal outcome tracking. Follow-up may extend over five years, capturing outcomes such as: Complete healing (epithelialization), Non-healing, Major and minor amputations, Mortality, and Loss to follow-up or transfer of care. Quality of care is assessed using wound-specific quality measures. The registry integrates real-world clinical care with research and quality improvement, supporting a learning healthcare system model.
Through secure tokenization, registry data may be linked to payer claims for comprehensive longitudinal analysis of healthcare utilization, interventions, hospitalizations, medication use, and long-term outcomes across care settings. This enables rigorous, policy-relevant evaluations of standard care and advanced wound therapies in routine practice. The robust patient and wound level data are suitable to understand the natural history of chronic wounds and ulcers and to create historical controls for prospective clinical trials.
- Conditions
- Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence, Vasculitis, Skin Ulcer, Leg Ulcer
- Being tested
- Usual care
- Keywords
- Qualified Clinical Data Registry, Quality Measures, Clinical Data Research Network, Real world data, chronic wounds, chronic ulcers, Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Pressure Injury, Arterial Ulcer, Traumatic Wound, Surgical Complication, Pyoderma Gangrenosum, Advanced Wound Care, Skin Substitutes, CAMPs, CTPs, Negative Pressure Wound Therapy, NPWT
- Medical subject headings
- Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence, Vasculitis, Skin Ulcer, Leg Ulcer, Pyoderma, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
Also called usual and customary care
advanced dressings, off-loading, venous ulcer compression, arterial screening
| Study group | Role | What they receive |
|---|---|---|
| chronic wound patients | This cohort includes pediatric and adult patients with one or more chronic wounds or ulcers treated in any site of care including hospital outpatient clinics, office-based practices, skilled nursing, and home. Data are captured prospectively during routine care using a purpose built certified EHR. Wounds include diabetic foot ulcers, venous leg ulcers, pressure ulcers/injuries, arterial ulcers, surgical wounds, traumatic wounds, and inflammatory ulcers. Interventions are at the discretion of the treating clinician and include standard and advanced wound therapies. Data collected include patient demographics, comorbid conditions, medications, total number of concomitant wounds per patient, wound characteristics, treatments, visit frequency, complications, and outcomes including healing, amputation, recurrence, hospitalization, and death. Patients may be followed for over five years. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healed
Wound closure by secondary intention
Measured: 1 year
Major amputation
Below the knee, above the knee
Measured: 1 year
Minor amputation
toe amputation, transmetatarsal amputation, midfoot amputation
Measured: 1 year
Patient Death
patient death while in treatment
Measured: 1 year
Secondary outcomes (1)
Percent surface area (PAR) reduction over time
Percent surface area reduction (PSAR) is defined as the percentage decrease in wound surface area from the initial documented size at baseline (first qualifying wound care visit) to subsequent visits over time. Wound surface area is measured using length × width, captured at the point of care using structured fields within the electronic health record (EHR) or electronic data capture (EDC) system. Values are recorded in cm² and used to calculate PSAR as:
[(Baseline area - Follow-up area) ÷ Baseline area] × 100
This metric is assessed at multiple time intervals, including 4 weeks, 12 weeks, 16 weeks, 6 months, and 12 months. PSAR is a key performance indicator for healing trajectory and is used to evaluate response to interventions. All wound types are included, and multiple wounds per patient are analyzed independently. Surface area measurements are case-mix adjusted using the Wound Healing Index for comparative effectiveness and quality reporting.
Measured: variable - measured at multiple intervals (e.g., 4, 12, 16, 24, and 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start1 Jan 2005
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- U.S. Wound Registry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline E Fife, MD, Principal investigator, Intellicure LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280733
- Sponsor's protocol ID
- USWR 001
- Acronym
- WOUNDJOURNEY
- Status last verified
- Jul 2025
- First submitted
- 29 Oct 2014
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected through the U.S. Wound Registry (USWR) may be made available to qualified researchers, payers, regulatory agencies, or industry partners upon request. Shared data may include demographics, comorbidities, wound characteristics, interventions, and outcomes captured longitudinally in a structured electronic health record (EHR) or data capture system. All shared data comply with HIPAA de-identification standards and may be subject to data use agreements and institutional review board (IRB) approval.
Publications
Fife CE, Walker D, Thomson B, Otto G. The safety of negative pressure wound therapy using vacuum-assisted closure in diabetic foot ulcers treated in the outpatient setting. Int Wound J. 2008 Jun;5 Suppl 2(Suppl 2):17-22. doi: 10.1111/j.1742-481X.2008.00467.x.
PubMed 18577134Fife CE, Walker D, Thomson B. Electronic Health Records, Registries, and Quality Measures: What? Why? How? Adv Wound Care (New Rochelle). 2013 Dec;2(10):598-604. doi: 10.1089/wound.2013.0476.
PubMed 24761335Horn SD, Fife CE, Smout RJ, Barrett RS, Thomson B. Development of a wound healing index for patients with chronic wounds. Wound Repair Regen. 2013 Nov-Dec;21(6):823-32. doi: 10.1111/wrr.12107. Epub 2013 Oct 17.
PubMed 24134202Carter MJ, Fife CE, Walker D, Thomson B. Estimating the applicability of wound care randomized controlled trials to general wound-care populations by estimating the percentage of individuals excluded from a typical wound-care population in such trials. Adv Skin Wound Care. 2009 Jul;22(7):316-24. doi: 10.1097/01.ASW.0000305486.06358.e0.
PubMed 20375969Fife CE, Carter MJ, Walker D, Thomson B. A retrospective data analysis of antimicrobial dressing usage in 3,084 patients. Ostomy Wound Manage. 2010 Mar 1;56(3):28-42.
PubMed 20368672Fife CE, Carter MJ, Walker D. Why is it so hard to do the right thing in wound care? Wound Repair Regen. 2010 Mar-Apr;18(2):154-8. doi: 10.1111/j.1524-475X.2010.00571.x. Epub 2010 Feb 16.
PubMed 20163568
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal, Real World, Observational Registry of Chronic Wounds and Ulcers and the Patients Who Have Them
- ClinicalTrials.gov ID
- NCT02280733
- Acronym / sponsor ID
- WOUNDJOURNEY / USWR 001
- Conditions
- Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence, Vasculitis, Skin Ulcer, Leg Ulcer
- Keywords
- Qualified Clinical Data Registry, Quality Measures, Clinical Data Research Network, Real world data, chronic wounds, chronic ulcers, Diabetic Foot Ulcer, Venous Leg Ulcer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- U.S. Wound RegistryUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 31 Oct 2014 (estimated)
- 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.
WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.
Detailed description
WOUNDJOURNEY is a longitudinal, real-world observational registry focused on the chronic disease burden and patient journey of individuals with chronic wounds and ulcers. Data collection began in 2005 and continues prospectively, capturing structured clinical data at the point of care using a purpose-built certified EHR or EDC system. These data are securely transmitted to the U.S. Wound Registry (USWR), a CMS-designated Qualified Clinical Data Registry (QCDR).
All major wound types are represented: Diabetic foot ulcers (DFUs), diabetic ulcers not on the foot, Venous leg ulcers (VLUs), Arterial ulcers, Pressure ulcers/injuries, Surgical complications, Traumatic wounds, Vasculitic/inflammatory, and sickle cell-related ulcers, and chronic non-pressure ulcers.
The registry collects detailed data on standard-of-care practices and advanced wound care interventions, including brand-specific information on: Advanced dressings (e.g., collagen, antimicrobial), Compression therapy, Offloading devices, Cellular and/or tissue-based products (CTPs) also called Cellular, Acellular, or Matrix-like Products (CAMPs) or "skin substitutes," Negative pressure wound therapy, MIST therapy (low-frequency ultrasound), Topical oxygen therapy (TOT), Hyperbaric Oxygen Therapy (HBOT), Topical growth factors (e.g., Becaplermin), Enzymatic and mechanical debridement, Fluorescent imaging for bacterial load, Topical antibiotics and antimicrobials, and other treatments.
The registry captures key elements of the patient journey, including: Frequency of debridement, Sites of care, number of patient visits and number of wound visits, Dressing changes, Use and timing of advanced therapies, Comorbid disease burden and clinical complexity, Patient Frailty, number of wounds and ulcers per patient, patient time in service, wound time service, patient and wound outcomes, the development of new wounds while in service and complication rates.
Wounds are risk stratified using the Wound Healing Index, enabling case-mix adjustment and longitudinal outcome tracking. Follow-up may extend over five years, capturing outcomes such as: Complete healing (epithelialization), Non-healing, Major and minor amputations, Mortality, and Loss to follow-up or transfer of care. Quality of care is assessed using wound-specific quality measures. The registry integrates real-world clinical care with research and quality improvement, supporting a learning healthcare system model.
Through secure tokenization, registry data may be linked to payer claims for comprehensive longitudinal analysis of healthcare utilization, interventions, hospitalizations, medication use, and long-term outcomes across care settings. This enables rigorous, policy-relevant evaluations of standard care and advanced wound therapies in routine practice. The robust patient and wound level data are suitable to understand the natural history of chronic wounds and ulcers and to create historical controls for prospective clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic wound patients | – | Other: Usual careThis cohort includes pediatric and adult patients with one or more chronic wounds or ulcers treated in any site of care including hospital outpatient clinics, office-based practices, skilled nursing, and home. Data are captured prospectively during routine care using a purpose built certified EHR. Wounds include diabetic foot ulcers, venous leg ulcers, pressure ulcers/injuries, arterial ulcers, surgical wounds, traumatic wounds, and inflammatory ulcers. Interventions are at the discretion of the treating clinician and include standard and advanced wound therapies. Data collected include patient demographics, comorbid conditions, medications, total number of concomitant wounds per patient, wound characteristics, treatments, visit frequency, complications, and outcomes including healing, amputation, recurrence, hospitalization, and death. Patients may be followed for over five years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic wounds or ulcers treated at participating sites in any US State and Puerto Rico. All patients and wounds are included without sampling. Each wound can be analyzed independently, even when multiple wounds exist on a single patient. Sampling Method: Non-Probability Sample Minimum Age: 0 Years Maximum Age: None (patients aged 90+ are reported in aggregate per HIPAA) Sex: All Gender Based: No Accepts Healthy Volunteers: No
Key inclusion criteria (6 listed)
- Presence of one or more chronic wounds or ulcers of any etiology
- Wound or ulcer must be treated at a participating site (which can be a hospital outpatient department, office, mobile practitioner, in the home setting, skilled nursing, etc.)
- Care must be documented using the purpose-built, wound-specific structured electronic health record (EHR) or electronic data capture (EDC) system
- All ages, including infants and patients aged 90 years or older (reported in aggregate in accordance with HIPAA de-identification standards)
- All sexes and gender identities
Key exclusion criteria (1 listed)
- -None (the registry includes all eligible patients treated at participating sites without sampling or exclusion criteria)
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 |
|---|---|---|
| Usual careAlso: usual and customary careadvanced dressings, off-loading, venous ulcer compression, arterial screening | Other | chronic wound patients |
Primary outcome
Healed
Time frame: 1 year
Wound closure by secondary intention
Major amputation
Time frame: 1 year
Below the knee, above the knee
Minor amputation
Time frame: 1 year
toe amputation, transmetatarsal amputation, midfoot amputation
Patient Death
Time frame: 1 year
patient death while in treatment
1 secondary outcome
Percent surface area (PAR) reduction over time
Time frame: variable - measured at multiple intervals (e.g., 4, 12, 16, 24, and 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 16 Jul 2025.
- Background: PubMed 18577134Fife CE, Walker D, Thomson B, Otto G. The safety of negative pressure wound therapy using vacuum-assisted closure in diabetic foot ulcers treated in the outpatient setting. Int Wound J. 2008 Jun;5 Suppl 2(Suppl 2):17-22. doi: 10.1111/j.1742-481X.2008.00467.x.
- Background: PubMed 24761335Fife CE, Walker D, Thomson B. Electronic Health Records, Registries, and Quality Measures: What? Why? How? Adv Wound Care (New Rochelle). 2013 Dec;2(10):598-604. doi: 10.1089/wound.2013.0476.
- Background: PubMed 24134202Horn SD, Fife CE, Smout RJ, Barrett RS, Thomson B. Development of a wound healing index for patients with chronic wounds. Wound Repair Regen. 2013 Nov-Dec;21(6):823-32. doi: 10.1111/wrr.12107. Epub 2013 Oct 17.
- Background: PubMed 20375969Carter MJ, Fife CE, Walker D, Thomson B. Estimating the applicability of wound care randomized controlled trials to general wound-care populations by estimating the percentage of individuals excluded from a typical wound-care population in such trials. Adv Skin Wound Care. 2009 Jul;22(7):316-24. doi: 10.1097/01.ASW.0000305486.06358.e0.
- Background: PubMed 20368672Fife CE, Carter MJ, Walker D, Thomson B. A retrospective data analysis of antimicrobial dressing usage in 3,084 patients. Ostomy Wound Manage. 2010 Mar 1;56(3):28-42.
- Background: PubMed 20163568Fife CE, Carter MJ, Walker D. Why is it so hard to do the right thing in wound care? Wound Repair Regen. 2010 Mar-Apr;18(2):154-8. doi: 10.1111/j.1524-475X.2010.00571.x. Epub 2010 Feb 16.
- US Wound Registry WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected through the U.S. Wound Registry (USWR) may be made available to qualified researchers, payers, regulatory agencies, or industry partners upon request. Shared data may include demographics, comorbidities, wound characteristics, interventions, and outcomes captured longitudinally in a structured electronic health record (EHR) or data capture system. All shared data comply with HIPAA de-identification standards and may be subject to data use agreements and institutional review board (IRB) approval.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Caroline E Fife, MD principal investigator
Intellicure LLC
1 site 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 and Pressure Ulcer, run by U.S. Wound Registry 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 6 inclusion and 1 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 16 Jul 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 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?
Contact Caroline E Fife, MD (800-603-7896, cfife@USwoundregistry.com; cfife@intellicure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healed (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02280733, which also lists 6 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 16 Jul 2025.