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Better Care Closer to Home: Enhancing Primary and Community Care

A legfontosabb adatok

Ki végzi
Universidad Complutense de Madrid
Hol
Dánia, Kanada és Spanyolország3 helyszín, 3 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
84 fő, tervezett
Kezdés
2027. ápr. 1.
Várható befejezés
2030. dec. 20.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease
A regiszteradat frissítve
2026. november 3.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

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.

Életkor
18 years or older
Nem
All sexes
A betegség stádiuma
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.

A részvétel fő kizáró okai

  • 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™

A regiszter feltételei, szó szerint

Mind a 13 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

3 országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • Intervention: Path Active™ with ulcer-risk alerts enabledA vizsgált kezelés

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

    Kezelés: 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 disabledMár használt kezelés, összehasonlításként

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

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

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

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

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Smart Technology for Remote Intervention in Diabetic Foot ulcEr Prevention in COMmunity Settings
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
A regiszteradat frissítve
2026. november 3.