To assess the efficacy of a TCC, a BTCC and a cast shoe with similar plantar soles on offloading the previous ulcer location in people with DM and peripheral neuropathy.
ID
Source
Brief title
Condition
- Diabetic complications
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dynamic in-shoe plantar peak pressure.
Secondary outcome
Force-time integral and perceived walking comfort.
Background summary
Diabetes Mellitus (DM) is one of the most common chronic diseases. In these
patients chronic non-healing ulcers of the foot are a significant problem. The
first line of treatment consists of offloading these ulcers to reduce (peak)
pressure at the ulcer location. Casting devices such as the total contact cast
(TCC), bivalved TCC, or cast shoes are commonly used offloading treatment
devices. However, while between-device variability of the plantar sole is
controlled, the effect of these devices on the plantar peak pressure has not
been directly investigated.
Study objective
To assess the efficacy of a TCC, a BTCC and a cast shoe with similar plantar
soles on offloading the previous ulcer location in people with DM and
peripheral neuropathy.
Study design
Intervention study with a within-subject design, with one measurement session.
Intervention
A Total Contact Cast, a Bivalved Total Contact Cast, a cast shoe and a
non-modelled cast shoe
Study burden and risks
There is no direct benefit for the subjects from the study and there will be a
slight risk to participate in the study. The burden of the study is mainly
determined by the time the measurements will take. The load of the measurements
is low.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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, 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.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52480.044.15 |
| OMON | NL-OMON20430 |