Foot orthoses for foot pain in people with diabetes and peripheral arterial disease

Phase 3

• Conditions: Metabolic and Endocrine - Diabetes; Diabetes; Peripheral arterial disease; Other - Pain management; Foot pain; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12607000300471
• Lead Sponsor: Podiatry Department, Westmead Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Subjects diagnosed with diabetes mellitus and peripheral arterial disease and ambulent foot pain.

Exclusion Criteria

wheelchair-bound; foot infection; current foot ulceration; amputation; pregnancy; recent foot trauma; current usage of prescribed foot orthoses; unwilling to wear supplied footwear, or lack of willingness to return for follow-up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Foot pain is measured with a questionnaire[At baseline and again at 8 weeks.]

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include plantar pressure, health related quality of life, functional ability, foot comfort, and activity levels.[All outcomes will be measured at baseline and again at 8 weeks.]