No registrations found.
ID
Source
Brief title
Health condition
diabetic foot ulcer
diabetische voet ulcus
Sponsors and support
Ziekenhuisgroep Twente (ZGT)
Department of surgery
Zilvermeeuw 1
7609 PP Almelo, The Netherlands
Intervention
Outcome measures
Primary outcome
Dynamic in-shoe plantar peak pressure.
Secondary outcome
Force-time integral and perceived walking comfort.
Background summary
Background of the study:
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, the effect of these devices on the plantar peak pressure has not been directly investigated with between-device variability of the plantar sole controlled.
Objective of the study:
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.
Primary objective: a comparison between a TCC, BTCC and a cast shoe, all with a Solo vinyl cast sole.
Secondary objectives: a comparison between a cast shoe and a non-modelled cast shoe, both with a Solo vinyl cast sole, and a comparison between a cast shoe with a Solo vinyl cast sole and a cast shoe with a Cellona sole.
Study design:
Intervention study with a within-subject design, with one measurement session.
Study population:
Minimal 16 people with diabetes mellitus, peripheral neuropathy and a healed foot ulcer will be measured in all conditions.
Study objective
Casting devices such as the total contact cast (TCC), bivalved TCC, or cast shoes are commonly used offloading treatment devices. The effect of these devices on the plantar peak pressure has not been directly investigated with between-device variability of the plantar sole controlled.
From this within-subject comparison, we can improve our understanding of the mechanisms used in offloading the diabetic foot, which may contribute to our understanding of the relation between offloading devices and healing of diabetic foot ulcers.
Study design
During one measurement session the dynamic in-shoe plantar peak pressure and force-time integral will be measured with the Pedar-X system (Novel GmbH, Munich, Germany). The perceived walking comfort will be assessed after completion of data collection in each offloading device using a visual analogue scale (VAS) with outcome score ranging from 0 (very uncomfortable) to 10 (very comfortable).
Intervention
Total contact cast
Bivalved total contact cast
Cast shoe
Non-modelled cast shoe
Cast shoe with Cellona sole
M. Westra
Zilvermeeuw 1
Almelo 7609 PP
The Netherlands
ma.westra@zgt.nl
M. Westra
Zilvermeeuw 1
Almelo 7609 PP
The Netherlands
ma.westra@zgt.nl
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4890 |
| NTR-old | NTR5137 |
| CCMO | NL52480.044.15 |
| OMON | NL-OMON44038 |