FindTrial
Sign In

Early recognition and treatment of sensory issues in urban and rural-tribal people with diabetes mellitus

Prediction and Management of Diabetic neuropathy in Urban, Rural and Tribal people of Raigad District, Maharashtra: The Foot-MaP study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/052057
Enrollment
10000
Registered
2023-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: G621- Alcoholic polyneuropathy Health Condition 2: A30- Leprosy [Hansens disease] Health Condition 3: E11- Type 2 diabetes mellitus Health Condition 4: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: Home exercise programme plus educational programe group: home exercise program targeted towards improve vascularity of foot and education for maintenance of foot hygiene for 12 week Con

Sponsors

MGM School of Physiotherapy MGM Institute of Health Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Observational study for Reference range : Healthy non diabetic individual in the from urban rural and tribal area Patients diagnosed with and without diabetic neuropathy, Hansenâ??s and Alcoholic neuropathy from urban rural and tribal area

Exclusion criteria

Exclusion criteria: Acute neurologic disorder affecting sensations such as acute demyelinating polyneuropathy, GBS Peripheral nerve injury involving lower extremity nerves Amputation of lower extremity Fractures, dislocation and soft tissue injuries of lower extremity more than 1 year Congenital and developmental deformities of lower extremity

Design outcomes

Primary

MeasureTime frame
Cross sectional study : Detection of diabetic neuropathy Comprehensive evaluation using plantar tissue stiffness, cutaneous sensory threshold, vibration perception threshold, temperature and newly developed device for measuring plantar tissue stiffness Validation study - Eight hundred and seventy people will be monitored every 12 weeks for a period of 1 year to detect change in the sensory profile including nerve conduction, vibration perception sense, temperature, plantar tissue stiffness, touch pressure sensation. Experimental study plantar tissue stiffness, cutaneous sensory threshold, vibration perception threshold, temperature. Ankle brachial Index Doppler Ultrasonography Timepoint: Cross sectional study Baseline Validation study Baseline Interventional study Baseline 12th week 24th week 36th week 48th week—

Secondary

MeasureTime frame
HBA1C for all participants for diagnosing Diabetes MellitusTimepoint: Baseline—

Countries

India

Contacts

Public ContactDr Rajani Mullerpatan

MGM Institute of Health Sciences MGM School of Physiotherapy

rajani.kanade@gmail.com02227437866

Outcome results

None listed

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