An interventional study of Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease in Diabetic Foot Disease and Recurrence, sponsored by Universidad Complutense de Madrid. Not yet recruiting at 3 sites in 3 countries. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Prevention
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:
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.
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.
Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
Presence of severe peripheral arterial disease (PAD) confirmed by non-invasive vascular testing (11), defined as any of the following:
Providing notifications based on the risk of developing plantar diabetic foot ulcers.
Device: Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease
Ulcer-risk alerts completely disabled. However, all other device functionalities will remain active, including pressure and temperature monitoring.
Device: Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease
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.
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 12 months
Foot-Care Behaviour
(Diabetic Foot Self-Care Questionnaire - DFSQ-UMA): Questionnaire scores will be calculated according to the validated scoring system
Time frame: 12 months
Other open studies at University of Quebec in Trois-Rivieres, Québec
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Other open studies at Steno Diabetes Center, Aalborg
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Other open studies at Diabetic Foot Unit, Universidad Complutense Madrid, Madrid
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Plan to share: Undecided
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