Diabetes Mellitus Clinical Trial
Official title:
Improving the Cost-effectiveness of Therapeutic Shoes for Diabetic Patients With a Previous Foot Ulcer Using an In-shoe Pressure Device
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. ;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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