A Randomised, Open Label, Controlled Clinical Study to Evaluate the Efficacy and Safety of CO2-Laser Treatment in Patients With Diabetic Infected Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Bacterial Load
研究概览
简要总结
The study is aimed at comparing debridement either with CO2 laser or traditional surgery in patients with infected diabetic foot ulcers. The principal endpoint is bacterial load immediately after treatment.
详细描述
The present study is designed to assess the antimicrobial effect of a single CO2 laser beam (DEKA SmartXide2 c80-El.En, Florence Italy) in the treatment of diabetic infected foot ulcers. CO2 laser debridement will be compared with standard surgical care. The primary efficacy endpoint will be the reduction of bacterial load between pre- and immediately after debridement. Secondary endpoints will be adverse events and pain during treatment. Two bacterial sample with a flocked nylon swab will be collected before and after debridement.
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
- •Infected foot ulcer (with clinical signs of infection)
- •Ulcer area between 0.5 and 150 cm2
- •More than 50% of ulcer area covered by fibrin and/or necrosis
- •Texas score <3
排除标准
- •Need for revascularization
- •Pregnancy or lactation
研究组 & 干预措施
CO2 laser
Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)
干预措施: CO2 laser (Procedure)
Traditional surgery
Ulcer debridement with traditional surgery
干预措施: traditional surgery (Procedure)
结局指标
主要结局
Bacterial Load
时间窗: Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.
Percent change in bacterial colonies from baseline.
次要结局
- Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis(during procedure)
- Fibrin: Percent of Ulcer Area Covered by Fibrin(Baseline and immediately after the end of procedure)
- Pain: Scores of Brief Pain Inventory(During procedure.)
- Granulation: Percent of Ulcer Area Covered by Granulation.(Baseline and immediately after procedure)
研究者
Edoardo Mannucci
Director, Diabetology
Azienda Ospedaliero-Universitaria Careggi