Optimization of the Surgical and Medical Management of Diabetic Foot Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 643
- 试验地点
- 2
- 主要终点
- Number of Participants with a clinical and microbiological remission of treated infection at 2 months
研究概览
简要总结
Diabetic foot problems, especially infections (DFI), require multiple resources including iterative surgeries and amputations, long-lasting antibiotic therapies, education, off-loading and eventually revascularization and appropriate foot-ware. Treatment is complicated, multidisciplinary, and marked with a high risk of recurrences.
This is a retrospective and prospective cohort with side studies of pathologies and academic research questions that cannot be separated from each other.
The investigators establish a retro-and prospective cohort of diabetic foot problems (ambulatory and hospitalized patients) and perform side studies to reduce the incidence of complications, and to reduce recurrences of DFI, cost and adverse events related to therapies.
Cohort: Prospective and retrospective cohort of all diabetic foot problems with emphasis on surgical and infectious variables.
Trial 1 (Randomized trial on residual infection after amputation):
Determination of the level of amputation per MRI followed by a randomization concerning the duration of post-amputation systemic antibiotic therapy, if there is residual bone infection.
Trial 2 (Randomized trial on infection without amputation):
Determination of the duration of systemic antibiotic therapy in diabetic foot infections without Amputation of the infection.
详细描述
Trial 1: At enrollment (Day 1), the investigator will prescribe empiric antibiotic treatment based on instructions provided in the protocol and determine the most appropriate route of administration (oral or IV) according to the patient's condition. Patients will be randomized in the ratio 1:1 between 1 versus 4 days for post-amputation soft tissue infections; and between 1 versus 3 weeks if there is microbiologically proven residual bone infection/contamination in the proximal stump samples of the residual bone.
Trial 2: At enrollment (Day 1), the investigator will prescribe empiric antibiotic treatment based on instructions provided in the protocol and determine the most appropriate route of administration (oral or IV) according to the patient's condition. Patients will be randomized in the ratio 1:1 between 10 versus 20 days for post-debridement soft tissue infections; and between 3 versus 6 weeks for diabetic foot osteomyelitis post.-debridement (without amputation).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diabetic foot infections or ischemia/necrosis with surgical amputation/disarticulation level in vicinity of MRI signs of infection
- •At least two months of follow-up from hospitalization
- •Patient signing to participate, including acceptance of local wound care, -off-loading and arterial re-vascularization (if clinically indicated).
排除标准
- •At least 5 cm of distance between amputation level and infection.
- •Any concomitant infection requiring more than 5 days of systemic antibiotic therapy
- •Eventual osteosynthesis material not removed
结局指标
主要结局
Number of Participants with a clinical and microbiological remission of treated infection at 2 months
时间窗: Through study completion, at 2 months
Remission is the absence of any anamnesis or clinics for persistent or recurrent infection
次要结局
- Rates of adverse events of antibiotic therapy(Through study completion, at 2 months)
- Anatomical Amputation Level Determination by MRI(At study entry, Day O)
- Numbers of Cost and resource reductions(Through study completion, at 2 months)
- Duration of wound healing time(Through study completion, at 2 months)
- Statistical evaluation of risk factors for failure of remission(2 years)
- Scales of Patient's satisfaction(Through study completion, at 2 months)