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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Other | 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 | Other | 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 | Other | 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 | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| block 1 | Other | shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements |
|
| Measure | Description | Time Frame |
|---|---|---|
| The cost-effectiveness of shoes produced with and without plantar pressure measurements. | approximately 10 weeks (at delivery of the shoes) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plantar pressure after wearing the therapeutic shoes for 3 months. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tom Melai, PhD | Contact | +31 43 3881398 | tom.melai@MaastrichtUniversity.nl |
| Name | Affiliation | Role |
|---|---|---|
| Nicolaas C Schaper, PhD, MD | Maastricht University Medical Center | Principal Investigator |
| Hans H Savelberg, PhD | Maastricht University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | 6200MD | Netherlands |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D011115 | Polyneuropathies |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| block 2 | Other | shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements |
|
| standard | Other | patient wears shoes produced with standard method |
|
| with measurements | Other | patient wears shoes produced with plantar pressure measurements |
|
| 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. | approximately 10 weeks (at delivery of the shoes) |
| Differences in plantar pressures between the two shoes produced. | approximately 10 weeks (at delivery of the shoes) |
| The use and usability of the shoes produced, measured with the questionnaire "Monitor Orthopaedic Shoes". | approximately 22 weeks (at follow-up) |
| Differences in plantar pressures between the two shoes produced. | approximately 22 weeks (at follow-up) |
| Smeets Loopcomfort | Sittard | 6135 LE | Netherlands |
|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |