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Off­loading the diabetic foot

Offloading the diabetic foot: a direct comparison of the total contact cast, bivalved total contact cast and cast shoe

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20430
Enrollment
16
Registered
2015-03-25
Start date
2015-04-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic foot ulcer diabetische voet ulcus

Interventions

Total contact cast Bivalved total contact cast Cast shoe Non-modelled cast shoe Cast shoe with Cellona sole

Sponsors

Dhr. E. Monteban Ziekenhuisgroep Twente (ZGT) Department of surgery Zilvermeeuw 1 7609 PP Almelo, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
Dynamic in­-shoe plantar peak pressure.

Secondary

MeasureTime frame
Force­-time integral and perceived walking comfort.

Contacts

Public ContactM. Westra

Ziekenhuisgroep Twente (ZGT) - Department of surgery

ma.westra@zgt.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)