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The Effects of Foot Orthoses on Diabetic Foot

The Effects Of Custom Molded Evazote Insoles vs. Silicone Insoles on Balance, Functional Strength and Energy Expenditure in Patients with Diabetic Neuropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024303
Enrollment
46
Registered
2020-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Custom Molded Evazote Insoles: Period - 2 weeks. Custom molded insole is made up of a combination of 3 materials: Evazote or micro-cellular polymer as the top layer that contacts the fo

Sponsors

Sarah Khalid
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with confirmed diagnosis of diabetes mellitus with onset duration of a minimum of 5 years 2. Diabetic Peripheral Neuropathy (Michigan Neuropathy Scoring Index > 2 ) 3. Male and female diabetic patients between the ages of 45-65 years 4. Ability to stand and ambulate independently without assistance or any mobility device 5. Patients who are free from any neuromuscular, musculoskeletal or vestibular disorders affecting the balance and lower limb functional strength.

Exclusion criteria

Exclusion criteria: 1. Patients with ulcers or history of ulcers on the plantar surface of the foot 2. Visual, hearing and/or cognitive impairments 3.Use of any foot insole or lower limb orthosis 4. Total or partial amputation of the lower limb 5. Presence of a non-diabetic neuropathy like Charcot-Marie-Tooth disease 6. History of any ankle-foot deformity like fractures in the last 6-8 months

Design outcomes

Primary

MeasureTime frame
Balance (Timed Up and Go Test), Lower Limb Functional Strength (Five Times Sit to Stand Test) and Energy Expenditure (Physiological Cost Index)Timepoint: After 2 weeks

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactSarah Khalid

Indian Spinal Injuries Center - Institute of Rehabilitation Sciences

saharawat.sakshi606@gmail.com8750494749

Outcome results

None listed

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