Importance of exercises and appropriate footwear in reducing foot pressure in adults with type 2 diabetes and loss of sensation in feet

Effectiveness of Comprehensive Rehabilitation Program on Maximum Plantar Pressure in Diabetic Foot Syndrome using Biomechanical Model

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019188

Enrollment

280

Registered

2019-05-16

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Intervention1: Comprehensive Rehabilitation program: Comprehensive Rehabilitation program includes Pain management, Structured exercises, Customized soles and standard care Control Intervention1: Stan

Eligibility

Inclusion criteria

Inclusion criteria: 1. Men and women between 35-70 years of age diagnosed with T2DM 2. Loss of protective sensation (inability to feel the 10-g monofilament at one or more sites 3. VPT greater or equal to 20 volts

Exclusion criteria

Exclusion criteria: 1. Current and history of ulceration, previous amputation or active foot infection. 2. Severe foot shape abnormality (e.g. Charcot foot) 3. Resting limb pain 4. The subjects underwent recent surgical intervention 5. Recent orthopedic surgery or musculoskeletal disorder in the last year.

Design outcomes

Primary

Measure	Time frame
Maximum Plantar Pressure using Biomechanical modelTimepoint: 1. Before intervention 2. At 12th week 3. At 24th week	—

Secondary

Measure	Time frame
1. Pressure time integral (PTI) 2. Navicular drop (ND) 3. Foot posture index (FPI) 4. Forefoot - Hind foot pressure (F/H) ratio 5. Balance by postural sway 6. WHO Quality of Life-brefTimepoint: 1. Before intervention 2. At 12th week 3. At 24th week	—

Countries

India

Contacts

Public ContactHrishikesh Yadav K

MANIPAL ACADEMY OF HIGHER EDUCATION

ajmaiya@gmail.com9845350823

Outcome results

None listed

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