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Smart insoles to help prevent foot ulcers in people with diabetes

Tests smart insoles for preventing foot ulcers in people with diabetic foot disease.

Key facts

Who runs it
Universidad Complutense de Madrid
Where
Canada, Denmark, and Spain3 sites in 3 countriesChoose a country to see its sites
Trial code
Registry title
Better Care Closer to Home: Enhancing Primary and Community Care
Status
Not yet recruiting
People taking part
84 people, planned
Starts
1 Apr 2027
Expected to end
20 Dec 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease
Record updated
3 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 1 or type 2 diabetes and nerve damage in the feet who have had a foot ulcer on the sole before. It tests Path Active™ smart insoles that track the risk of a new ulcer.

Age
18 years or older
Sex
All sexes
Disease stage
Type 1 or Type 2 Diabetes Mellitus with diabetic peripheral neuropathy (nerve damage), and a past plantar diabetic foot ulcer (sore on the sole). People must walk at least 100 meters without mobility aids.

Main reasons for not taking part

  • An open diabetic foot ulcer at the time of joining
  • Severe peripheral arterial disease: ABI < 0.5 (or > 1.4 with non-compressible arteries), TBI < 0.3, or toe systolic pressure < 30 mmHg
  • Leg amputation that limits walking or needs walking aids (partial toe amputation is allowed)
  • Dementia, moderate-to-severe memory or thinking problems, or inner-ear or balance disorders
  • Body weight > 130 kg (287 lb), or no smartphone that works with Path Active™

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • 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
  • 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
  • Lower-limb amputation that prevents minimal ambulation or requires the use of walking aids (partial toe amputations will be permitted)
  • Body weight > 130 kg, as this may affect the accuracy and performance of the device

This trial has no sites in United States.

It has sites in 3 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Intervention: Path Active™ with ulcer-risk alerts enabledTreatment being tested

    Providing notifications based on the risk of developing plantar diabetic foot ulcers.

    Treatment: 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 disabledExisting treatment, for comparison

    Ulcer-risk alerts completely disabled. However, all other device functionalities will remain active, including pressure and temperature monitoring.

    Treatment: Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Smart Technology for Remote Intervention in Diabetic Foot ulcEr Prevention in COMmunity Settings
Plain-language title
Smart insoles to help prevent foot ulcers in people with diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
3 November 2026