The Effects of Foot Orthoses on Diabetic Foot

Not Applicable

Completed

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

• Registration Number: CTRI/2020/03/024303
• Lead Sponsor: Sarah Khalid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-07-12
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 46

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified