Clinical Efficacy of Therapeutic Footwear With a Rigid Rocker Sole in the Prevention of Reulceration in Patients With Diabetes Mellitus and Diabetic Polineuropathy: a Prospective and Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Presence of diabetic foot ulcer
研究概览
简要总结
This research presents a randomized clinical trial which analyzes the efficacy of a rigid rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot patients. The hypothesis of the research is the use of a rigid rocker sole reduces the recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.
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
- 是
入选标准
- •Type 1 or 2 diabetic patients regardless of the pharmacotherapy that they receive.
- •Adult patients of both sexes.
- •Peripheral neuropathy patients.
- •Patients without wounds or ulcers at the examination time.
- •Patients with a foot ulcers history.
- •Patients with or without minor amputation prior to the inclusion time in the present study.
- •Patients who don´t need gait support mechanisms such as walking sticks, crutches, splints or any other devices which interferes with the autonomous development of the gait.
排除标准
- •Patients with mayor amputation.
- •Patients with rheumatic disease that affect the feet.
- •Patients with peripheral neuropathy of different etiology to Diabetes mellitus.
- •Patients with several critical ischemia criteria, defined by TACS II guideline.
研究组 & 干预措施
Experimental Group
Rigid rocker sole footwear
干预措施: Rigid Rocker Sole Footwear (Device)
Control Group
Therapeutic footwear
干预措施: Therapeutic Footwear (Device)
结局指标
主要结局
Presence of diabetic foot ulcer
时间窗: through study completion, an average of 6 months
The Wagner system assesses ulcer depth and the presence of osteomyelitis or gangrene using the following grades: grade 0 (pre- or post-ulcerative lesion), grade 1 (partial/full-thickness ulcer), grade 2 (probing to tendon or capsule), grade 3 (deep with osteitis), grade 4 (partial foot gangrene) and grade 5 (whole foot gangrene
次要结局
- Ankle Joint movility(through study completion, an average of 6 months)
- Mobility of the First metatarsal Joint(through study completion, an average of 6 months)
- IPAQ (International Physical Activity Questionnaires)(through study completion, an average of 6 months)
- Deformities(through study completion, an average of 6 months)
- Subtalar Joint Movements(through study completion, an average of 6 months)
- Ankle - Brachial Index (ABI)(through study completion, an average of 6 months)
- Physical Activity Questionnaire(through study completion, an average of 6 months)
- Foot Type(through study completion, an average of 6 months)
- Toe - Brachial Index (TBI)(through study completion, an average of 6 months)
- Sensorimotor neuropathy(through study completion, an average of 6 months)
研究者
Mateo López Moral
Clinical Research
Universidad Complutense de Madrid