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Smart Footwear intervention for the prevention of Diabetic foot ulcer

Smart Bio-Sensor footwear, a unique device combining multi-sensor, AI-driven healing interventions for the prevention of Diabetic foot Ulcer - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104960
Enrollment
432
Registered
2026-02-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E139- Other specified diabetes mellituswithout complications

Interventions

Intervention1: Smart Biosensor Footwear: The device records pressure, temperature, moisture and sweat glucose levels continuously (12 hours/day during use), with automated data logging at predefined i

Sponsors

Indian Council of Medical Research
Lead Sponsor
AIIMS Nagpur
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients at risk for pressure ulcers/diabetic foot ulcers Age more than 18 years No active ulcer at baseline

Exclusion criteria

Exclusion criteria: Active ulcer at enrolment Severe comorbid conditions affecting skin integrity Patients not willing to participate

Design outcomes

Primary

MeasureTime frame
Reduction in Diabetic Foot Ulcer occurrenceTimepoint: Outcome will be monitored throughout the 3-month study period, with clinical assessments at baseline, 1 and 3 months.—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactDr Unnati Shirbhate

AIIMS Nagpur

unnatishirbhate0791@gmail.com7020106697

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026