Effect of insole top covers on pressure relief and satisfaction in patients with diabetes

Completed

• Conditions: Diabetic foot; diabetic neuropathy; 10012653

• Registration Number: NL-OMON55590
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Diabetes mellitus
- Peripheral neuropathy
- Diabetic foot risk classification categories 2 and 3 (i.e. presence of
peripheral vascular disease or foot deformity, or a history of foot ulceration).
- Possession of or prescription of semi-custom-made or fully custom-made
footwear

Exclusion Criteria

- Active ulceration
- Inability to walk at least 100m
- Amputation of more than 2 toes (not the hallux)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Peak plantar pressure</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Patient satisfaction<br /><br>In-vivo durability of insole top layer material</p><br>