The primary objective of this investigator initiated project is to determine whether the use of the WalkinSense in the production of new fully customized therapeutic footwear for diabetic patients with a history of foot ulceration results in lower…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint
The cost-effectiveness of the WiS shoes and standard shoes, expressed as Euro*s/
kPa plantar pressure reduction, calculated by determining:
a) production costs of the therapeutic footwear (materials and manpower),
b) the change in plantar peak pressure (measured with WalkinSense) at the area
of previous ulceration during wearing the prescribed therapeutic footwear,
calculated as peak plantar pressure in normal shoes minus in-shoe peak plantar
pressures in the therapeutic shoes at the moment of final delivery of the shoes
by the shoemaker
Secondary outcome
a) The change in peak plantar pressure at the area of previous ulceration after
3 months wearing the prescribed therapeutic footwear of the WiS and
Standard-shoes
b) The change in the highest plantar peak pressure in the foot with a history
of prior ulceration after 3 months of the WiS and Standard-shoes
c) The number of new patients reported and visible shoe and/or diabetic foot
problems (including foot ulcers) during the 3 months follow-up period while
wearing the WiS or Standard-shoes
d) Differences in production techniques, materials and procedures of the WiS
and Standard-shoes
e) Differences in plantar pressures measured with WalkinSense between the WiS
and Standard-shoes
f) The use and usability of the WiS-shoes compared to the Standard-shoes
measured with the MOS (please see additional files)
Background summary
Elevated plantar foot pressures are a risk factor for the development of
plantar foot ulcers and redistribution of the abnormal plantar load is the
basis of the management of these ulcers. The efficacy of redistributing
abnormal plantar loads as a preventive strategy, by manufacturing therapeutic
shoes and customized insoles, is less clear. Although these shoes are produced
with the aim to lower elevated plantar pressures, they frequently remain
elevated. This relative poor efficacy is -at least in part- related to our poor
understanding of the factors determining plantar foot pressures and the
response to specific interventions as well as to the lack of simple, in daily
practice useable, techniques that can reliably measure in-shoe plantar
pressures. Recently the WalkinSense system was introduced that enables
measurement of these values with a relative simple and cheap technique.
Study objective
The primary objective of this investigator initiated project is to determine
whether the use of the WalkinSense in the production of new fully customized
therapeutic footwear for diabetic patients with a history of foot ulceration
results in lower costs per kPa pressure reduction compared to current standard
production (Phase 1). The second objective is to explore if a difference can be
observed in durability of the pressure reducing effect and development of
(pre-) ulcerative lesions between the two different pair of shoes during a
3-month period (phase 2).
Study design
Phase I is a randomised non-blinded trial with blinded endpoint assessment,
with a duration of maximal 6 months for each participant. For each participant
2 pairs of shoes will be manufactured by 2 different shoemakers, one using
WalkinSense (WiS-shoe) and one according current standard production procedures
(Standard-shoe). After final delivery of the shoes participants will be
randomised, and in Phase 2 half of them will wear for 3 months the WiS-shoe and
the other half the Standard-shoe.
Intervention
In Phase 1 two pair of fully customized shoes will be developed for all
participants by two different shoe-makers, one with the use of WalkinSense and
one without. In the Phase 2 a pilot study is performed in which participants
will wear one of these pairs of customised shoes during a 3 month observation
period.
Study burden and risks
Phase 1. All participants will undergo a standardized clinical examination at
inclusion of the study. To determine the main outcome parameter in all
participants pressure measurements will be performed with and without shoes at
delivery of the therapeutic footwear by the shoemaker to the patient
(approximately 5-8 weeks after baseline), and 3 months after delivery. During
the production of the WiS-shoe in-shoe pressure measurements will be performed
by the shoemaker using the WalkinSense system. All the measurements are
non-invasive and can be part of regular care and the research team has
extensive experience with these or comparable techniques both in research and
clinical practice. The number of visits to the shoe-maker company will be
doubled by participating in this trial as 2 pairs of shoes will be manufactured
by 2 different shoemakers, but these travel costs will be reimbursed. The
benefit for the participants is that the extra pair of shoes will be without
the payment they have to make (Euro 137,50), as therapeutic shoes are not
completely reimbursed in the Netherlands. Phase 2. Plantar pressure
measurements will be performed 3 months after delivery.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Patients with diabetes (determined by a physician) with a history of a prior diabetic foot ulceration in the past 5 years, for whom a new pair of therapeutic footwear is prescribed by a physician.
- Patients who already have a pair of therapeutic footwear can be included as long as the production of a new pair of fully customized shoe wear is needed, according to the treating rehabilitation specialist.
- Diabetic neuropathy based on clinical examination performed by the researcher (defined as loss of Achilles tendon reflex combined with loss of protective sensation, i.e. loss of sensation of 10 g monofilament in at least 2 areas of each feet) after exclusion of other causes of neuropathy.
- Receiving regular preventive, podiatric, foot care in the diabetic foot clinic (at least 1x 3 months).
- Informed written consent.
Exclusion criteria
- Severe peripheral arterial disease in one or both legs, i.e.: ABI < 0.5 or, in case of incompressible leg arteries during ABI measurement, absence of both foot pulses in one or two feet
- Not motivated for therapeutic footwear despite intensive education.
- Active foot ulcer or any pre-ulcerative lesion on either foot that according to the treating physician needs immediate specific off-loading measures (e.g. felt or debridement).
- Previous vascular intervention in one or both of the legs 3 months before inclusion
- End-stage renal disease (creatinin clearance < 20 ml/min or dialysis).
- Severe mobility impairment, i.e. not able to walk 100 meters without assistance.
- Any amputation more proximal than toe(s) amputation, except a single ray amputation is allowed, based on visual inspection.
- Severe visual impairment, i.e. not able to read a newspaper after correction.
- Active cancer.
- Severe cardiac or pulmonary failure (NYHA class 4), based on observation of symptoms at rest and the interview.
- Severe oedema that interferes with the efficacy of the prescribed therapeutic footwear, based on visual inspection.
- Chronic drug abuse.
- Severe psychiatric illness that would interfere with treatment or follow-up.
- Hospital admission at the time of inclusion.
- Any condition that according to the treating clinician or researcher would interfere with the follow-up visits.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02061059 |
| CCMO | NL46691.068.13 |