Toe Amputations in Patients With Diabetes - the Effect of Leaving a Wound Open or Closing on Healing and Ambulation After Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Wound healed
研究概览
简要总结
This study is a randomized controlled trial (RCT) to evaluate outcome after toe amputation due to diabetic foot infection. Aim of this RCT is to evaluate wound healing and functional outcome based, whether wound is closed or left open. As a part of this study, emerging technology of thermal imaging is evaluated as a possible tool to predict complication after amputation.
详细描述
Patients with diabetes undergoing toe amputation due to infection, are recruited for this study. Based on randomization, wound is either closed or left open during the amputation procedure. If primary closure is not possible (e.g. deep abscess) and patient is randomized to closed group, delayed closure is performed when feasible. Patients are followed up in outpatient clinic 3 month after amputation. Primary outcome is wound healing that is evaluated during follow ups in the outpatient clinic. Functional outcome is evaluated with PROM questionnaires preoperatively and during the follow up.
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
- •Toe amputation due to diabetic foot infection
排除标准
- •Deep foot infection
- •No clinical infection (amputation due to trauma, deformity or uninfected necrosis)
结局指标
主要结局
Wound healed
时间窗: 3 months
Percentage of patients with completely healed (no dehiscence, necrosis etc.) wound in 3 month control visit
次要结局
- Complications(3 months)
- Functional outcome: TESS(3 months)
- Functional outcome: 15D(3 months)
- Functional outcome: FHSQ(3 months)
研究者
Miska Vuorlaakso
Principal Investigator
Tampere University Hospital