Improving the Cost-effectiveness of Therapeutic Shoes for Diabetic Patients With a Previous Foot Ulcer Using an In-shoe Pressure Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Maastricht University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- The cost-effectiveness of shoes produced with and without plantar pressure measurements.
- Last Updated
- 12 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
The cost-effectiveness of shoes produced with and without plantar pressure measurements.
Time Frame: approximately 10 weeks (at delivery of the shoes)
Secondary Outcomes
- 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))
- 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))
- Differences in plantar pressures between the two shoes produced.(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))
- Change in plantar pressure after wearing the therapeutic shoes for 3 months.(approximately 22 weeks (at follow-up))