Health Condition 1: E106- Type 1 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Innovative Diabetic Foot Mat: A portable, battery-operated diagnostic device designed to simultaneously detect plantar pressure hotspots and assess vibration per
Sponsors
D.Purushothaman
Eligibility
Inclusion criteria
Inclusion criteria: 18 years or older. Diagnosed with Type 1 or Type 2 diabetes mellitus. Participants with or without peripheral neuropathy
Exclusion criteria
Exclusion criteria: History of foot or leg surgery within the last 6 months. Presence of active infections or ulcers on feet. Pregnant or planning to become pregnant during the study period. Any severe cardiovascular, neurological, or orthopedic conditions that could affect the ability to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study is expected to enhance diabetic foot care by accurately identifying pressure points and assessing vibration perception, leading to timely interventions and improved patient outcomes. Additionally, it aims to empower patients and provide valuable insights for healthcare providers in managing diabetic complications.Timepoint: At baseline, at 4 weeks, and at 8 weeks after initial assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reliability of the innovative deviceTimepoint: Day 0 (15–30 min & within 2 h); Day 7 ±2 days.;Usability of the deviceTimepoint: Immediately after assessment on Day 0.;Patient comfort during device assessmentTimepoint: Immediately after assessment on Day 0; optional safety/comfort check at 24 h ±6 h by phone.;Predictive ulcer riskTimepoint: Month 3 ±2 weeks; Month 6 ±3 weeks; Month 12 ±4 weeks. | — |
Countries
India
Contacts
Public ContactPurushothaman D
Saveetha Institute of Medical and Technical Sciences
Outcome results
None listed