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Smart Technology for Remote Intervention in Diabetic Foot ulcEr Prevention in COMmunity Settings
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · European Union
interventional
84
3 countries
3
Study Start
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 20, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 23, 2026
Actual (reported)October 29, 2026
Actual (reported)April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 20, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence and time to first Ulceration:
The number of new DFUs for each participant will be recorded monthly during the study period by respective clinical sites using electronic medical records
12 months
Quality of Life
Participant responses at each time point will be scored using standard EQ-5D-5L algorithms.
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
12 months
Providing notifications based on the risk of developing plantar diabetic foot ulcers.
Ulcer-risk alerts completely disabled. However, all other device functionalities will remain active, including pressure and temperature monitoring.
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.
University of Quebec in Trois-Rivieres
Québec, Canada
Steno Diabetes Center
Aalborg, Denmark
Diabetic Foot Unit, Universidad Complutense Madrid
Madrid, Madrid, 28040, Spain
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.
Lise Pape
Walk With Path
Adherence
erived 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
12 months
Foot-Care Behaviour
(DFSQ-UMA): Questionnaire scores will be calculated according to the validated scoring system
12 months
Contact the study team to confirm eligibility.
First Submitted
October 23, 2026
First Posted
October 29, 2026
Study Start
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 20, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 20, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
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