|- candidate number||21863|
|- NTR Number||NTR5137|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-mrt-2015|
|- Secondary IDs||NL52480.044.15 CCMO |
|- Public Title||Offloading the diabetic foot|
|- Scientific Title||Offloading the diabetic foot: a direct comparison of the total contact cast, bivalved total contact cast and cast shoe|
|- ACRONYM||Offloading the diabetic foot|
|- hypothesis||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.
|- Healt Condition(s) or Problem(s) studied||diabetic ulcer|
|- 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
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-apr-2015|
|- planned closingdate||31-dec-2015|
|- Target number of participants||16|
|- Interventions||Total contact cast|
Bivalved total contact cast
Non-modelled cast shoe
Cast shoe with Cellona sole
|- Primary outcome||Dynamic in-shoe plantar peak pressure.|
|- Secondary outcome||Force-time integral and perceived walking comfort.|
|- Timepoints||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).|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. M. Westra|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.J. van Netten|
|- Sponsor/Initiator ||Ziekenhuisgroep Twente|
(Source(s) of Monetary or Material Support)
|- Brief 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.
Intervention study with a within-subject design, with one measurement session.
Minimal 16 people with diabetes mellitus, peripheral neuropathy and a healed foot ulcer will be measured in all conditions.
|- Main changes (audit trail)|
|- RECORD||25-mrt-2015 - 21-mei-2015|