Off­loading the diabetic foot

Completed

• Conditions: diabetic foot ulcerdiabetische voet ulcus

• Registration Number: NL-OMON20430
• Lead Sponsor: Dhr. E. MontebanZiekenhuisgroep Twente (ZGT)Department of surgeryZilvermeeuw 17609 PP Almelo, The Netherlands

Brief Summary

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Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

People with diabetes who are at risk for plantar foot ulceration will be included. They must be 18 years or older, must have peripheral neuropathy and a healed plantar foot ulcer located at the hallux or metatarsal phalangeal joint (MTP) 1, 2, 3, 4 or 5 that was treated with a casting device. People must also present with one or more foot deformities, including claw/hammer toes, hallux valgus, hallux rigidus, prominent metatarsal heads, pes cavus, pes planus, rearfoot valgus and/or rearfoot varus.

Exclusion Criteria

People will be excluded if they aren’t able to walk a distance of 20 m repeatedly without walking aid. They will also be excluded if the previous ulcer location has been amputated, or they have Charcot deformity, equines foot deformity, treatment for serious medical conditions or injuries other than DM that may interfere with lower limb
function (walking).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dynamic in­-shoe plantar peak pressure.

Secondary Outcome Measures

Name	Time	Method
Force­-time integral and perceived walking comfort.