Offloading the diabetic foot: a direct comparison of the total contact cast, bivalved total contact cast and cast shoe
- Conditions
- diabetic foot ulcer - foot wound1001265310007963
- Registration Number
- NL-OMON44038
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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, an unhealed and/or 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 or a non-ischemic non-infected plantar foot ulcer that is currently being treated using 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.
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 <p>Dynamic in-shoe plantar peak pressure.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Force-time integral and perceived walking comfort.</p><br>