The effect of personalised 3D printed metamaterial insoles in combination with a prefabricated offloading device for the reduction of plantar pressure in healthy individuals

Not Applicable

Not yet recruiting

• Conditions: Diabetes-related foot ulceration; Peripheral neuropathy; Metabolic and Endocrine - Diabetes; Neurological - Other neurological disorders

• Registration Number: ACTRN12624001175561
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-25
• Last Update Posted: 30 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Able to walk for 10 minutes without use of assistive devices (e.g. walking frame, walking stick).Available to attend a follow up appointment 2-4 weeks after the initial appointment.

Exclusion Criteria

Evidence of peripheral arterial disease.Loss of peripheral protective sensation.Current or history of previous foot ulceration, Charcot neuroarthropathy, previous amputation of foot (at any level).Previous amputation to lower limb.History of falls in previous 12 months.Current or recent (4 weeks) self-reported foot or leg pain.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak plantar pressure[This will be assessed using the Novel Pedar X plantar pressure measurement system - This is a validated commercial system for measuring plantar pressure. This will be assessed using a validated 12 step protocol. Immediate effects following a brief acclimatisation period (at least 2 minutes) wearing the insole condition.]