Diabetic Foot DiseaseNCT07905664
Better Care Closer to Home: Enhancing Primary and Community Care
A study testing Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease in people with Diabetic Foot Disease and Recurrence, run by Universidad Complutense de Madrid at 3 sites in 3 countries.
Trial summary
60 million people in Europe have diabetes (DM) and up to 34% (20.4 million) of them are at risk of developing diabetic foot ulcers (DFUs) in their lifetime (1). However, current primary and community care is suboptimal with 40% of DFUs recurring within a year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot Disease, Recurrence
- What is being tested?
- Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Apr 2027to 20 Dec 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients of either sex aged 18 years or older.
- Patients with the capacity to provide written informed consent and to comply rigorously with all study procedures.
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus.
- Presence of diabetic peripheral neuropathy.
- History of a plantar diabetic foot ulcer.
- Patients able to walk at least 100 meters without the assistance of mobility aids and who own a smartphone compatible with the Path Active™ technology.
Who cannot join
- Presence of an active diabetic foot ulcer at the time of study enrollment. Use of non-compressible orthopedic devices that prevent the use or fitting of the Path Active™ device.
- Presence of severe peripheral arterial disease (PAD) confirmed by non-invasive vascular testing (11), defined as any of the following:
- Ankle-Brachial Index (ABI) < 0.5 (or > 1.4 in the presence of non-compressible arteries).
- Toe-Brachial Index (TBI) < 0.3, or Toe systolic pressure < 30 mmHg.
- Lower-limb amputation that prevents minimal ambulation or requires the use of walking aids (partial toe amputations will be permitted).
- Diagnosis of dementia or the presence of moderate-to-severe cognitive impairment.
Show all 9Show fewer
- Vestibular or inner-ear disorders that impair balance and may increase the risk of falls.
- Body weight > 130 kg, as this may affect the accuracy and performance of the device.
- Any medical, psychological, or social condition that, in the opinion of the investigator, may interfere with study participation or place the participant at additional risk.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Francisco Javier Álvaro-Afonso, Professor, PhD contact
3 sites in 3 countries
Canada1 site
University of Quebec in Trois-Rivieres
Québec
Magali Brousseau-Foley, PhD, magali.brousseau-foley@uqtr.ca
Spain1 site
Diabetic Foot Unit, Universidad Complutense Madrid
Madrid, Madrid, 28040
Mateo López-Moral, Professor, PhD, +34 652311573, matlopez@ucm.es
Francisco Javier Álvaro-Afonso, Professor, PhD
About this study
Official title: Smart Technology for Remote Intervention in Diabetic Foot ulcEr Prevention in COMmunity Settings
60 million people in Europe have diabetes (DM) and up to 34% (20.4 million) of them are at risk of developing diabetic foot ulcers (DFUs) in their lifetime (1). However, current primary and community care is suboptimal with 40% of DFUs recurring within a year. Path Active (PA) is a digital health tool composed of smart insoles and a Bluetooth-connected app, which remotely monitors users' DFU risk, reducing their reliance on institutionalised care.
This project will use interdisciplinary approaches to assess PA's ability to strengthen primary and community care systems (Subtopic 1) in culturally and socioeconomically diverse settings. We will take an ecosystem approach, incorporating multiple stakeholders including end-user patients,healthcare professionals, policy makers and potential commercial partners, investigating PA through economic, social, and clinical lenses. The project will pilot PA in >100 individuals across 3 different countries (Canada, Denmark, and Spain) over 18 months. This will allow us to carry out:
Read more
- Implementation research: Mapping PA implementation in diverse care settings, identifying local barriers to PA's adoption and necessary changes to promote PA integration into community care.
- Service and ICT research: End user-testing to facilitate iterative design improvements, ensuring PA is culturally appropriate.
- Health economics and policy research: Investigate international policy impact on the health economics surrounding PA and inform PA's market plan for different health systems.
- Pilots: Gather evidence on PA's effectiveness in preventing DFUs and investigate/tackle any potential efficacy differences between cultures.
- Business development: Scale up PA production and map potential stakeholders in member sites.
Overall, STRIDE-COM represents a significant step toward integrating innovative digital health solutions into primary care across Europe/Canada, establishing a replicable model for wearable technologies.
Read the detailed description
Background: There are 60 million people in Europe with DM (WHO) and up to 34% (20.4 million) of these patients develop DFUs in their lifetime. DFUs take significant time to heal, 12% never heal and result in amputations within 5 years. In Europe, total treatment cost per patient for DFU in 2005 was €10,091, with amputation (€889) and hospitalisation (€3892) approximating 50% of the total direct cost (3). Since the incidence of DFUs is approximately 2% annually in the diabetic population in Europe, the annual costs would be approximately €12B (€10,091*0.02*60,000,000).
State-of-the-art/unmet need: DFU management is suboptimal with 40% of DFUs reoccurring within 1 year, affecting quality of life (QoL). Current care is based around frequent clinic visits (up to weekly) for foot checks. This overreliance on institutionalised care is inconvenient and often impractical for those in rural areas without access to nearby specialised care and thus have a higher DFU risk than urban counterparts.
Technical challenge addressed: STRIDE-COM addresses the need for enhanced primary and community care of DFUs by providing remote monitoring via Path Active (PA). PA is a digital health tool composed of smart temperature- and pressure-sensing insoles and a Bluetooth-connected app, which monitors users' DFU risk, alerting them and their healthcare professionals (HCP) when they are at high risk. PA allows DFU care to be returned to the primary/community level, allowing users to come in only when necessary and empower them to take control of their own health, offloading their feet to reduce DFU risk. STRIDE-COM addresses the challenge of implementing PA across different language/cultural/regulatory contexts. It does so by piloting PA in three different countries and taking into account the economic, socioeconomic, cultural, geographical, and policy differences between various regions which could impact the rollout of such smart wearable solutions.
Scope Transformative innovation - Strengthening primary and community care: STRIDE-COM will transform both primary and community care for individuals at risk of DFUs. PA's remote monitoring will shift the current clinical pathway for foot monitoring from specialist care to community/primary care levels.
Overall, this will reduce burdens on the entire healthcare system by reducing frequent podiatry clinic visits and preventing DFUs, which are a major healthcare burden. PA provides a simple, intuitive, user-friendly tool to reduce the fragmentation of DFU care in different EU countries and beyond and provide more equitable and integrated care regardless of geographical location.
- Conditions
- Diabetic Foot Disease, Recurrence
- Being tested
- Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease
- Keywords
- Diabetes, Healthtech, Ulcers, Remote, Smart, Monitoring, Ulcer prevention, Biomechanics
- Medical subject headings
- Recurrence, Diabetes Mellitus, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot diseaseDevice
The investigational intervention is Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease by monitoring plantar temperature and plantar pressure patterns, and transmitting these data to a mobile application.
Participants in both study arms will receive the Path Active™ insoles and the corresponding mobile application. The only difference between the study groups is whether the ulcer-risk alert functionality is enabled or disabled. In the intervention group, the system will generate alerts based on the assessed risk of developing plantar diabetic foot ulcers, whereas in the control group all ulcer-risk alerts will be disabled. All other device functionalities, including plantar pressure and temperature monitoring, will remain active in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Path Active™ with ulcer-risk alerts enabled | Experimental | Providing notifications based on the risk of developing plantar diabetic foot ulcers. Receives: Device: Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease |
| Control: Path Active™ with all ulcer-risk alerts completely disabled | Active comparator | Ulcer-risk alerts completely disabled. However, all other device functionalities will remain active, including pressure and temperature monitoring. Receives: Device: Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrent events
The number of new diabetic foot ulcer events for each participant will be recorded monthly during the study period by respective clinical sites using electronic medical records
Measured: 12 months
Quality of Life
Participant responses at each time point will be scored using standard EuroQol 5-Dimension 5-Level (EQ-5D-5L) algorithms.
Measured: 12 months
Ulcer Location
Ulcer site (plantar vs. non-plantar) will be recorded by podiatrists at our respective clinical sites in the case of ulcer occurrence
Measured: 12 months
Adherence
Derived from both self-reported data (collected at Months 9 and 18) and PA sensor data (hours worn/day). Compliance will be defined using the threshold of ≥4.5 hours/day
Measured: 12 months
Foot-Care Behaviour
(Diabetic Foot Self-Care Questionnaire - DFSQ-UMA): Questionnaire scores will be calculated according to the validated scoring system
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 posted29 Oct 2026
- Study start1 Apr 2027 (estimated)
- Primary completion20 Dec 2029 (estimated)
- Study completion20 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot DiseaseStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomized, double-blind, parallel-group clinical trial is proposed to evaluate the effectiveness of the Path Active™ Smart Insole System technology in the prevention of diabetic plantar foot ulcers (DFUs) in individuals at high risk of developing a DFU (history of previous ulceration). Participants will be randomly assigned in a 1:1 ratio to one of two parallel study groups: Group 1 - Intervention: Path Active™ with alerts enabled based on the risk of developing plantar diabetic foot ulcers. Group 2 - Control: Path Active™ with all ulcer risk alerts completely disabled. However, all other functions will remain active (pressure and temperature monitoring). The study will be conducted across different countries and healthcare settings (Spain, Denmark, and Canada). In Spain, two previously identified independent participating centers will be involved. Each center will have a Principal Investigator responsible for participant enrollment a
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Francisco Javier Álvaro Afonso
- Responsible party
- Principal investigator, Mateo López-Moral, DPM, PhD, Universidad Complutense de Madrid
- Investigators
- Lise Pape, Study chair, Walk With Path
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905664
- Sponsor's protocol ID
- THCS-Consortium RCT
- Other IDs
- THCS Grant 101095654
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lavery LA, Petersen BJ, Linders DR, Bloom JD, Rothenberg GM, Armstrong DG. Unilateral remote temperature monitoring to predict future ulceration for the diabetic foot in remission. BMJ Open Diabetes Res Care. 2019 Aug 6;7(1):e000696. doi: 10.1136/bmjdrc-2019-000696. eCollection 2019.
PubMed 31423317
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Technology for Remote Intervention in Diabetic Foot ulcEr Prevention in COMmunity Settings
- ClinicalTrials.gov ID
- NCT07905664
- Acronym / sponsor ID
- THCS-Consortium RCT
- Conditions
- Diabetic Foot Disease, Recurrence
- Keywords
- Diabetes, Healthtech, Ulcers, Remote, Smart, Monitoring, Ulcer prevention, Biomechanics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Francisco Javier Álvaro Afonso
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 20 Dec 2029 (estimated)
- Study completion
- 20 Dec 2030 (estimated)
- First posted
- 29 Oct 2026 (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.
60 million people in Europe have diabetes (DM) and up to 34% (20.4 million) of them are at risk of developing diabetic foot ulcers (DFUs) in their lifetime (1). However, current primary and community care is suboptimal with 40% of DFUs recurring within a year. Path Active (PA) is a digital health tool composed of smart insoles and a Bluetooth-connected app, which remotely monitors users' DFU risk, reducing their reliance on institutionalised care.
This project will use interdisciplinary approaches to assess PA's ability to strengthen primary and community care systems (Subtopic 1) in culturally and socioeconomically diverse settings. We will take an ecosystem approach, incorporating multiple stakeholders including end-user patients,healthcare professionals, policy makers and potential commercial partners, investigating PA through economic, social, and clinical lenses. The project will pilot PA in >100 individuals across 3 different countries (Canada, Denmark, and Spain) over 18 months. This will allow us to carry out:
- Implementation research: Mapping PA implementation in diverse care settings, identifying local barriers to PA's adoption and necessary changes to promote PA integration into community care.
- Service and ICT research: End user-testing to facilitate iterative design improvements, ensuring PA is culturally appropriate.
- Health economics and policy research: Investigate international policy impact on the health economics surrounding PA and inform PA's market plan for different health systems.
- Pilots: Gather evidence on PA's effectiveness in preventing DFUs and investigate/tackle any potential efficacy differences between cultures.
- Business development: Scale up PA production and map potential stakeholders in member sites.
Overall, STRIDE-COM represents a significant step toward integrating innovative digital health solutions into primary care across Europe/Canada, establishing a replicable model for wearable technologies.
Detailed description
Background: There are 60 million people in Europe with DM (WHO) and up to 34% (20.4 million) of these patients develop DFUs in their lifetime. DFUs take significant time to heal, 12% never heal and result in amputations within 5 years. In Europe, total treatment cost per patient for DFU in 2005 was €10,091, with amputation (€889) and hospitalisation (€3892) approximating 50% of the total direct cost (3). Since the incidence of DFUs is approximately 2% annually in the diabetic population in Europe, the annual costs would be approximately €12B (€10,091*0.02*60,000,000).
State-of-the-art/unmet need: DFU management is suboptimal with 40% of DFUs reoccurring within 1 year, affecting quality of life (QoL). Current care is based around frequent clinic visits (up to weekly) for foot checks. This overreliance on institutionalised care is inconvenient and often impractical for those in rural areas without access to nearby specialised care and thus have a higher DFU risk than urban counterparts.
Technical challenge addressed: STRIDE-COM addresses the need for enhanced primary and community care of DFUs by providing remote monitoring via Path Active (PA). PA is a digital health tool composed of smart temperature- and pressure-sensing insoles and a Bluetooth-connected app, which monitors users' DFU risk, alerting them and their healthcare professionals (HCP) when they are at high risk. PA allows DFU care to be returned to the primary/community level, allowing users to come in only when necessary and empower them to take control of their own health, offloading their feet to reduce DFU risk. STRIDE-COM addresses the challenge of implementing PA across different language/cultural/regulatory contexts. It does so by piloting PA in three different countries and taking into account the economic, socioeconomic, cultural, geographical, and policy differences between various regions which could impact the rollout of such smart wearable solutions.
Scope Transformative innovation - Strengthening primary and community care: STRIDE-COM will transform both primary and community care for individuals at risk of DFUs. PA's remote monitoring will shift the current clinical pathway for foot monitoring from specialist care to community/primary care levels.
Overall, this will reduce burdens on the entire healthcare system by reducing frequent podiatry clinic visits and preventing DFUs, which are a major healthcare burden. PA provides a simple, intuitive, user-friendly tool to reduce the fragmentation of DFU care in different EU countries and beyond and provide more equitable and integrated care regardless of geographical location.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multicenter, randomized, double-blind, parallel-group clinical trial is proposed to evaluate the effectiveness of the Path Active™ Smart Insole System technology in the prevention of diabetic plantar foot ulcers (DFUs) in individuals at high risk of developing a DFU (history of previous ulceration). Participants will be randomly assigned in a 1:1 ratio to one of two parallel study groups: Group 1 - Intervention: Path Active™ with alerts enabled based on the risk of developing plantar diabetic foot ulcers. Group 2 - Control: Path Active™ with all ulcer risk alerts completely disabled. However, all other functions will remain active (pressure and temperature monitoring). The study will be conducted across different countries and healthcare settings (Spain, Denmark, and Canada). In Spain, two previously identified independent participating centers will be involved. Each center will have a Principal Investigator responsible for participant enrollment a
| Arm | Type | Receives |
|---|---|---|
| Intervention: Path Active™ with ulcer-risk alerts enabled | Experimental | Device: Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot diseaseProviding notifications based on the risk of developing plantar diabetic foot ulcers. |
| Control: Path Active™ with all ulcer-risk alerts completely disabled | Active comparator | Device: Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot diseaseUlcer-risk alerts completely disabled. However, all other device functionalities will remain active, including pressure and temperature monitoring. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients of either sex aged 18 years or older.
- Patients with the capacity to provide written informed consent and to comply rigorously with all study procedures.
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus.
- Presence of diabetic peripheral neuropathy.
- History of a plantar diabetic foot ulcer.
Key exclusion criteria (9 listed)
- Presence of an active diabetic foot ulcer at the time of study enrollment. Use of non-compressible orthopedic devices that prevent the use or fitting of the Path Active™ device.
- Presence of severe peripheral arterial disease (PAD) confirmed by non-invasive vascular testing (11), defined as any of the following:
- Lower-limb amputation that prevents minimal ambulation or requires the use of walking aids (partial toe amputations will be permitted).
- Diagnosis of dementia or the presence of moderate-to-severe cognitive impairment.
- Vestibular or inner-ear disorders that impair balance and may increase the risk of falls.
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 |
|---|---|---|
| Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot diseaseThe investigational intervention is Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease by monitoring plantar temperature and plantar pressure patterns, and transmitting these data to a mobile application. Participants in both study arms will receive the Path Active™ insoles and the corresponding mobile application. The only difference between the study groups is whether the ulcer-risk alert functionality is enabled or disabled. In the intervention group, the system will generate alerts based on the assessed risk of developing plantar diabetic foot ulcers, whereas in the control group all ulcer-risk alerts will be disabled. All other device functionalities, including plantar pressure and temperature monitoring, will remain active in both groups. | Device | Control: Path Active™ with all ulcer-risk alerts completely disabled, Intervention: Path Active™ with ulcer-risk alerts enabled |
Primary outcome
Incidence of recurrent events
Time frame: 12 months
The number of new diabetic foot ulcer events for each participant will be recorded monthly during the study period by respective clinical sites using electronic medical records
Quality of Life
Time frame: 12 months
Participant responses at each time point will be scored using standard EuroQol 5-Dimension 5-Level (EQ-5D-5L) algorithms.
Ulcer Location
Time frame: 12 months
Ulcer site (plantar vs. non-plantar) will be recorded by podiatrists at our respective clinical sites in the case of ulcer occurrence
Adherence
Time frame: 12 months
Derived from both self-reported data (collected at Months 9 and 18) and PA sensor data (hours worn/day). Compliance will be defined using the threshold of ≥4.5 hours/day
Foot-Care Behaviour
Time frame: 12 months
(Diabetic Foot Self-Care Questionnaire - DFSQ-UMA): Questionnaire scores will be calculated according to the validated scoring system
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 3 Nov 2026.
- Results publication: PubMed 31423317Lavery LA, Petersen BJ, Linders DR, Bloom JD, Rothenberg GM, Armstrong DG. Unilateral remote temperature monitoring to predict future ulceration for the diabetic foot in remission. BMJ Open Diabetes Res Care. 2019 Aug 6;7(1):e000696. doi: 10.1136/bmjdrc-2019-000696. eCollection 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot Disease
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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EDX110 Randomized Control Trial for Treatment of DFUs
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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.
Francisco Javier Álvaro-Afonso, Professor, PhD contact
Lise Pape study chair
Walk With Path
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease in people with Diabetic Foot Disease and Recurrence, run by Universidad Complutense de Madrid at 3 sites in 3 countries.
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 9 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Denmark, Spain. 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 Mateo López-Moral, Professor, PhD (+34 652311573, matlopez@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of recurrent events (time frame: 12 months). The study lists 5 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 NCT07905664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.