NCT02061059

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

Improving the Cost-effectiveness of Therapeutic Shoes for Diabetic Patients With a Previous Foot Ulcer Using an In-shoe Pressure Device

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Maastricht University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Polyneuropathies

Interventions

Type	Name	Description
OTHER	block 1	shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements
OTHER	block 2	shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
OTHER	standard	patient wears shoes produced with standard method
OTHER	with measurements	patient wears shoes produced with plantar pressure measurements

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2014-02-12
• Last updated: 2014-02-12

Locations

2 sites across 1 country: Netherlands