Effect of Foot-ankle Exercise Using Elastic Band on Diabetic Foot Ulcer Incidence in Patient With Diabetes Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- diabetic foot ulcer (DFU) incidence
研究概览
简要总结
The goal of this clinical trial is to learn if foot-ankle exercise can prevent diabetic foot ulcer incidence in patient with diabetes neuropathy. It will also learn about the effect of foot-ankle exercise on improvement of diabetes neuropathy severity, glycemic control, brain-derived neurotropic factor, walking speed, foot ankle range of motion, callus. The main questions it aims to answer are:
- Does foot-ankle exercise lower the number of diabetic ulcer incidence
- Does foot-ankle exercise lower the diabetes neuropathy severity
- Does foot-ankle exercise improve glycemic control
- Does foot-ankle exercise improve brain-derived neurotrophic factor
- Does foot-ankle exercise improve walking speed
- Does foot-ankle exercise improve foot ankle range of motion
- Does foot-ankle exercise lower the number of callus incidence
详细描述
Researchers will compare intervention group foot-ankle exercise used elastic band to a control group to see if foot-ankle exercise work to prevent diabetic foot ulcer incidence in patient with diabetes neuropathy
Participants will:
- Do foot-ankle exercise for three times a week with non-consecutive day for 1 year
- Report the incidence of callus and diabetic foot ulcer whenever they have
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •can walk minimal 10 meters
- •neuropathy diabetic
排除标准
- •active ulcer
- •fracture on foot area
- •diabetic ulcer history
结局指标
主要结局
diabetic foot ulcer (DFU) incidence
时间窗: for a year
DFU, defined as a wound in the area below the ankle that reaches at least the epidermis and part of the dermis, as diagnosed by an internist
次要结局
- diabetic neuropathy examination score(0, 12 weeks, and a year)
- control glyacemic(0, 12 weeks, and a year)
- brain derived neurotrophic factor(0, 12 weeks, and a year)
- walking speed(0, 12 weeks, and a year)
- foot ankle range of motion(0, 12 weeks, and a year)
- callus insidence(0, 12 weeks, and a year)
- neuropathy symptom score(0, 12 weeks, and a year)
研究者
Maria Suryani
Principal investigator
St Elisabeth School Health Science