Cost-effectiveness of In-shoe Pressure Measurement for Therapeutic Shoes
NCT ID: NCT02061059
Last Updated: 2014-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2014-03-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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group 1
group is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements.
group is assigned to "standard": wears shoes produced with standard procedure
block 1
shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements
standard
patient wears shoes produced with standard method
group 2
group is assigned to "block 1": shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements
group is assigned to "with measurements": wears shoes produced with plantar pressure measurements
block 1
shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements
with measurements
patient wears shoes produced with plantar pressure measurements
group 3
group is assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
group is assigned to "standard": wears shoes produced with standard procedure
block 2
shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
standard
patient wears shoes produced with standard method
group 4
group assigned to "block 2": shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
group is assigned to "with measurements": wears shoes produced with plantar pressure measurements
block 2
shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
with measurements
patient wears shoes produced with plantar pressure measurements
Interventions
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block 1
shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements
block 2
shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
standard
patient wears shoes produced with standard method
with measurements
patient wears shoes produced with plantar pressure measurements
Eligibility Criteria
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Inclusion Criteria
* neuropathy
* prescription of therapeutic footwear
* diabetic foot ulcer in the last 5 years
* receiving regular preventive foot care
* written informed consent
Exclusion Criteria
* not motivated to wear therapeutic footwear
* active foot ulcer
* recent vascular intervention
* severe mobility impairment
* amputation more proximal than toes, except a single ray amputation is allowed.
* severe visual impairment
* active cancer
* severe cardiac/ pulmonary failure
* severe oedema
* chronic drug abuse
* severe psychiatric illness
* hospital admission at the time of inclusion
* any condition that may interfere with follow-up visits.
ALL
No
Sponsors
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Maastricht University
OTHER
Responsible Party
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Principal Investigators
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Nicolaas C Schaper, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Hans H Savelberg, PhD
Role: STUDY_DIRECTOR
Maastricht University
Locations
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Maastricht University
Maastricht, , Netherlands
Smeets Loopcomfort
Sittard, , Netherlands
Countries
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Central Contacts
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Other Identifiers
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13-1-112.3
Identifier Type: -
Identifier Source: org_study_id
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