Effectiveness of Insoles Provided to Diabetic Patients at Risk to Develop Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- In shoe plantar pressure measurement
研究概览
简要总结
Introduction: Insoles and shoes are frequently prescribed to prevent foot ulcers in patients at risk of diabetes. A combination of neuropathy and foot deformities raises the risk from 1% to between 4-7% according to the Swedish National Board of Health and Welfare, Guidelines Diabetes Care 2010. Preventative care, which includes foot care, annual inspection of the feet, education and prescription of insoles in combination with well fitting shoes are supposed to decrease the risk of ulcers and prevent amputation. Further research is, however, needed to evaluate the effectiveness of these commonly prescribed insoles. The aim of this study is to compare three different types of insoles with respect to pressure distribution. Every 6 months follow-up is assessed until 24 months is reached.
详细描述
Patients included in the study were randomized into 3 different groups. Group number 1 and 2 got custom made insoles out of EVA (Ethyl Vinyl Acetate) with different hardness 35 and 55 shore respectively. Group nr 3 got prefabricated insole with support of the medial arch and in the forefoot. The top layer was covered with a 2 mm cushioned material, 25 shore, made out of microcellular urethane. All patients were recommended to wear good walking shoes with a semi rigid outer sole and stable heel counter. One and the same technician made the casting and fabricated the insoles as well as delivered the devices. Deliverance occured 2-3 weeks after the first visit.
At deliverance base line measurement was assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First time visitor to Dept of Prosthetics & Orthotics
- •Age > 18 year
- •Be able to walk independently
- •Be able to read and understand Swedish
排除标准
- 未提供
研究组 & 干预措施
Prefabricated insoles
Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material.
干预措施: Prefabricated insoles (Other)
Custom made insoles 35 shore
Custom made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate
干预措施: Custom made insoles 35 shore (Other)
55 shore Custom made insoles
Custom made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate
干预措施: 55 shore Custom made insole (Other)
结局指标
主要结局
In shoe plantar pressure measurement
时间窗: up to 24 months
次要结局
- Gait analysis(every 6 months until 24 months is reached)
研究者
Ulla Hellstrand Tang
Certified Prosthetist & Orthotist
Sahlgrenska University Hospital, Sweden