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

Not Applicable

• Conditions: Polyneuropathies; Diabetes Mellitus
• Interventions: Other: block 1; Other: block 2; Other: with measurements; Other: standard

• Registration Number: NCT02061059
• Lead Sponsor: Maastricht University

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.

Study Timeline

• Status Verified: 2014-02
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-11
• Last Update Submitted: 2014-02-11
• Study First Posted: 2014-02-12
• Last Update Posted: 2014-02-12
• Study Start: 2014-03
• Primary Completion: 2015-04
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	block 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
group 2	block 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 "with measurements": wears shoes produced with plantar pressure measurements
group 4	with measurements	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
group 2	with measurements	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
group 3	standard	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
group 1	standard	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
group 3	block 2	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
group 4	block 2	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

Primary Outcome Measures

Name	Time	Method
The cost-effectiveness of shoes produced with and without plantar pressure measurements.	approximately 10 weeks (at delivery of the shoes)

Secondary Outcome Measures

Name	Time	Method
Differences in plantar pressures between the two shoes produced.	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.	approximately 10 weeks (at delivery of the shoes)	Qualitative measure of differences in production process of the shoes produced with or without plantar pressure measurements.
The number of participants with reported and/ or visible new diabetic foot problems, such as ulcera or pre-ulcerative lesions.	approximately 22 weeks (at follow-up)	The number of diabetic foot problems serves as an additional measure of the quality of the therapeutic shoes produced.
Change in plantar pressure after wearing the therapeutic shoes for 3 months.	approximately 22 weeks (at follow-up)
The use and usability of the shoes produced, measured with the questionnaire "Monitor Orthopaedic Shoes".	approximately 22 weeks (at follow-up)

Trial Locations

Locations (2)

Maastricht University; 🇳🇱 Maastricht, Netherlands

Smeets Loopcomfort; 🇳🇱 Sittard, Netherlands