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

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus, Polyneuropathies

Intervention / Treatment
-----------------
* Other: block 1
* Other: block 2
* Other: standard
* Other: with measurements


Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group 1<br>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 | Other: block 1<br>* shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements<br>Other: standard<br>* patient wears shoes produced with standard method<br>|
| Other: group 2<br>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 | Other: block 1<br>* shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements<br>Other: with measurements<br>* patient wears shoes produced with plantar pressure measurements<br>|
| Other: group 3<br>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 | Other: block 2<br>* shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements<br>Other: standard<br>* patient wears shoes produced with standard method<br>|
| Other: group 4<br>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 | Other: block 2<br>* shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements<br>Other: with measurements<br>* patient wears shoes produced with plantar pressure measurements<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost-effectiveness of shoes produced with and without plantar pressure measurements. |  | approximately 10 weeks (at delivery of the shoes) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) |