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Evaluation of the presence and severity of Diabetic foot neuropathy.

A clinical investigation evaluating the presence and severity of Diabetic foot neuropathy using VIBRASENSE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/09/045640
Enrollment
120
Registered
2022-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Control Intervention1: Nil: Nil

Sponsors

Ayati Devices Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Type 1 diabetes over 5 years Type 2 diabetes of any durartion with or withou history of diagnosed diabetic peripheral neuropathy confirmed by medical records Patients who will be able to give written consent

Exclusion criteria

Exclusion criteria: Active foot ulceration Visual evidence of recently healed foot ulceration Lower limb amputation of any kind or diagnosed peripheral neuropathy of any origin other than diabetes

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of the VIBRASENSE to detect presence and severity of DPN device compared with the other standard methods of detecting DPNTimepoint: Single visit

Secondary

MeasureTime frame
NoneTimepoint: None

Countries

India

Contacts

Public ContactDr Nikhila Pinjala

Apollo Hospitals

npvascular@gmail.com23607777-6059

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026