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A new strategy for identifying early signs of foot problems in people with high blood sugar to prevent future foot complications

Novel approach for early screening and prevention of foot complications in T2 Diabetes Mellitus at rural community level of coastal districts; Manipal Amputation Prevention Program among People Living with Type 2 Diabetes Mellitus - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090097
Enrollment
2000
Registered
2025-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Training of health professions: Training will cover diabetic foot care, footwear selection, and patient communication, supplemented by workshops, hands-on training, and screening forms.

Sponsors

RailTel Corporation of India Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for healthcare professionals: 1.1. Individuals who are doctors, nurses, public health professionals, physiotherapists, and ASHA workers 1.2. Healthcare professionals of any age 1.3. Individuals who are working in healthcare setups in Udupi district 2. Inclusion criteria for the general population: 2.1. People of the Udupi district 2.2. Individuals more than 45 years of age 2.3. People with or without diabetes 3. Inclusion criteria for patients with type 2 diabetes mellitus: 3.1. Individuals who are more than 45 years of age 3.2. Individuals with pre-diabetes and diabetes

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for healthcare professionals: 1.1. Healthcare professionals are not willing to participate due to inadequate availability 1.2. Short-term visiting healthcare professionals from outside the Udupi district 2. Exclusion criteria for the general population: 2.1. People from outside the Udupi district 3. Exclusion criteria for patients with type 2 diabetes mellitus: 3.1. People with locomotory dysfunction 3.2. Psychiatric dysfunction

Design outcomes

Primary

MeasureTime frame
For the primary objective, the training of healthcare professionals, outcomes include questionnaire. For the secondary objective, the screening of type 2 diabetes mellitus patients, outcome measures will be used Neuropathic assessments: - Monofilament testing - Vibration perception threshold Vascular assessments: - Thermometry (using IR thermometer) - Ankle Brachial Index (ABI) Musculoskeletal assessment: - muscle strength - muscle tightnessTimepoint: The questionnaire will be administered prior to training session and post training session. For screening, all outcome measures are conducted or used at one time point at baseline during screening.

Secondary

MeasureTime frame
Plantar pressure assessment using the Harris mat Footwear assessmentsTimepoint: Plantar pressure assessment & footwear assessments will be conducted at two time points one at baseline & after 3months

Countries

India

Contacts

Public ContactDr G Arun Maiya

Manipal College of Health Professions, MAHE Manipal

arun.maiya@manipal.edu9845350823

Outcome results

None listed

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