Clinical Efficacy of an External Shoe Lift in the Contralateral Limb to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Percentage of diabetic foot ulcers healed
研究概览
简要总结
Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Plantar diabetic foot ulcer.
- •Wagner I and II classification.
- •Ulcer area between 1-30 cm square centimeters.
- •HbA1c values in the last three months below 11%
- •Ankle brachial Index (ABI) value > 0.5.
排除标准
- •Diagnosis of Critical Limb Ischaemia definid by TASCC II guideline.
- •Presence of foot ulcer in both feet.
- •Presence of soft tissue infection.
- •Osteomyelitis suspicion.
- •Peripheral neuropathy due to different causes than diabetes.
研究组 & 干预措施
External shoe lift
Those patients allocated in the experimental group will be supplemented with a external shoe lift in the contralateral limb in their conventional shoes to compensate the differences with the affected foot (using a offloading device to active ulcer).
干预措施: External shoe lift (Device)
Standard of care
Those patients allocated in the control group will not be supplemented, they will be treated with a standard of care treatment.
结局指标
主要结局
Percentage of diabetic foot ulcers healed
时间窗: 12 weeks
Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate
次要结局
- Time to healing(30 weeks)
- Percentage of diabetic foot ulcers healed(20 weeks)
- Adherence to offloading device(3 days)
研究者
Raúl Juan Molines Barroso, Phd
Clinical Professor
Universidad Complutense de Madrid