Improving the Cost-effectiveness of Therapeutic Shoes for Diabetic Patients With a Previous Foot Ulcer Using an In-shoe Pressure Device
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- The cost-effectiveness of shoes produced with and without plantar pressure measurements.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neuropathy
- •prescription of therapeutic footwear
- •diabetic foot ulcer in the last 5 years
- •receiving regular preventive foot care
- •written informed consent
排除标准
- •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.
结局指标
主要结局
The cost-effectiveness of shoes produced with and without plantar pressure measurements.
时间窗: approximately 10 weeks (at delivery of the shoes)
次要结局
- 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))