Comparison of Posterior Slab Cast With Total Contact Cast in the Management of Diabetic Foot Ulcers: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- The primary outcome measure in this study was healing of the ulcer at 6 months.
研究概览
简要总结
The goal of this clinical trial is to compare wound healing and foot related outcomes in people with plantar diabetic foot ulcer using Total contact cast (TCC) or Posterior slab cast (PSC). Ninety-nine people with neuropathic DFUs were randomized to use TCC (n=51) or PSC (n=48) together with standard of care for up to 6 months.
Researchers will compare rate of healing of ulcer at the end of 6 months, percentage reduction in the surface area, time taken to heal and patient satisfaction.
Participants will:
- Use TCC or PSC as off-loading till the ulcer heals for upto 6 months
- Visit the clinic once every 2 weeks for follow ups when inspection of the wound will be done for wound dressing, wound debridement and infection control when necessary
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with diabetes
- •a single neuropathic plantar DFU
- •Ulcer belonging to Wagner grade 2 and 3
排除标准
- •Persons with bilateral DFUs
- •peripheral arterial disease (ABPI <0.8)
- •stage 4 and 5 chronic kidney disease [estimated glomerular filtration rate (eGFR) <30 ml/min/m2]
- •active Charcot arthropathy
- •history of steroid intake within the past 3 months
结局指标
主要结局
The primary outcome measure in this study was healing of the ulcer at 6 months.
时间窗: 6 months
We compared the rate of healing of ulcers and time taken to heal.
次要结局
- The secondary outcome measure was the rate of wound size reduction at 4 weeks and patient satisfaction.(6 Months)
研究者
Ghanshyam Goyal
Head of the Department, Diabetology & Diabetic Foot, ILS Hospital, saltlake, Kolkata
ILS Hospital, Salt Lake