Cost-effectiveness of In-shoe Pressure Measurement for Therapeutic Shoes

N/AUnknownNCT02061059

Maastricht University40 enrolled

Overview

The purpose of this study is determine whether the use of plantar pressure measurements in the production of customized therapeutic footwear for patients with diabetes and a history of foot ulceration results in lower production costs and more pressure relief, compared to the standard production. A secondary objective is to explore if a difference in durability can be observed in pressure reduction and development of (pre-) ulcerative lesions between the shoes produced with and without plantar pressure measurements.

For each patient two pairs of shoes will be produced by two shoemakers, one using plantar pressure measurements and one according current standard production procedures. The patient will wear one of these two pairs of shoes during a period of 3 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus Polyneuropathies

Interventions

block 1OTHER

shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements

block 2OTHER

shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements

standardOTHER

patient wears shoes produced with standard method

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * diabetes * neuropathy * prescription of therapeutic footwear * diabetic foot ulcer in the last 5 years * receiving regular preventive foot care * written informed consent Exclusion Criteria: * peripheral arterial disease * 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.

Locations (2)

Maastricht University

Maastricht, Netherlands

Smeets Loopcomfort

Sittard, Netherlands

Outcomes

Primary Outcomes

The cost-effectiveness of shoes produced with and without plantar pressure measurements.

Time frame: approximately 10 weeks (at delivery of the shoes)

Secondary Outcomes

Change in plantar pressure after wearing the therapeutic shoes for 3 months.

Time frame: approximately 22 weeks (at follow-up)

The number of participants with reported and/ or visible new diabetic foot problems, such as ulcera or pre-ulcerative lesions.

The number of diabetic foot problems serves as an additional measure of the quality of the therapeutic shoes produced.

Time frame: approximately 22 weeks (at follow-up)

Differences in production techniques, materials and procedures used by the two shoemakers to produce the two pair of shoes.

Qualitative measure of differences in production process of the shoes produced with or without plantar pressure measurements.

Time frame: approximately 10 weeks (at delivery of the shoes)

Differences in plantar pressures between the two shoes produced.

Time frame: approximately 10 weeks (at delivery of the shoes)

The use and usability of the shoes produced, measured with the questionnaire "Monitor Orthopaedic Shoes".

Time frame: approximately 22 weeks (at follow-up)

Differences in plantar pressures between the two shoes produced.

Time frame: approximately 22 weeks (at follow-up)

Central Contacts

Tom Melai, PhD

CONTACT

+31 43 3881398 tom.melai@MaastrichtUniversity.nl

Data from ClinicalTrials.gov

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