Clinical trial NCT02061059: Cost-effectiveness of In-shoe Pressure Measurement for Therapeutic Shoes
Official title: Improving the Cost-effectiveness of Therapeutic Shoes for Diabetic Patients With a Previous Foot Ulcer Using an In-shoe Pressure Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Polyneuropathies
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The cost-effectiveness of shoes produced with and without plantar pressure measurements.
timeFrame: approximately 10 weeks (at delivery of the shoes)
Secondary outcomes:
measure: Change in plantar pressure after wearing the therapeutic shoes for 3 months.
timeFrame: approximately 22 weeks (at follow-up)
measure: The number of participants with reported and/ or visible new diabetic foot problems, such as ulcera or pre-ulcerative lesions.
timeFrame: approximately 22 weeks (at follow-up)
measure: Differences in production techniques, materials and procedures used by the two shoemakers to produce the two pair of shoes.
timeFrame: approximately 10 weeks (at delivery of the shoes)
measure: Differences in plantar pressures between the two shoes produced.
timeFrame: approximately 10 weeks (at delivery of the shoes)
measure: The use and usability of the shoes produced, measured with the questionnaire "Monitor Orthopaedic Shoes".
timeFrame: approximately 22 weeks (at follow-up)
measure: Differences in plantar pressures between the two shoes produced.
timeFrame: approximately 22 weeks (at follow-up)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
city: Sittard
country: Netherlands
facility: Smeets Loopcomfort
Study officials:
affiliation: Maastricht University Medical Center
name: Nicolaas C Schaper, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Hans H Savelberg, PhD
role: STUDY_DIRECTOR
References: