Total Contact Soft Cast in Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Complete Healing Rates
研究概览
简要总结
To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.
详细描述
This study will evaluate whether the use of a total contact soft cast with or without a removable cam boot is as effective in healing diabetic foot ulcers as more commonly used offloading methods.
The total contact soft cast will consist of wound dressing of choice to the ulcer and a plantar foot accommodative offloading felt pad for all foot ulcers, with 4x4 gauze pads added to the arch to create a rocker bottom for metarsophalangeal joint (MPJj) and plantar heel ulcers. The next layers will be:
- Unna boot from MPJs to just below the knee,
- Sterile Kerlix from MPJs to just below the knee
- Sterile 4 inch Kling wrap from the MPJs to just below the knee,
- Four inch coban from MPJs to just below the knee, and
- Ace wraps from MPJs to just below the knee
Removable diabetic cam boot will be used in patients willing and capable of using it. If patient does not want to use diabetic cam boot then surgical shoe or regular shoe would be options.
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
- Single (Outcomes Assessor)
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
- •- Any adult with a diabetic foot ulcer
排除标准
- •Allergy to Calamine or Zinc oxide
- •Inability to have leg wrapped
- •Inability to be seen weekly or as needed
- •Unable or unwilling to consent
- •Prisoners
- •Persons lacking capacity to consent
结局指标
主要结局
Complete Healing Rates
时间窗: 16 weeks
Complete healing is defined as complete epithelization of the ulcer. Outcome will be reported in days.
次要结局
- Patient Compliance with Use of the Total Contact Soft Cast(16 weeks)
- Patient Complications(16 weeks)