CTRI/2025/02/080469招募中不适用
Single blind randomized clinical trial on 4 weeks versus 6 weeks antibiotic therapy in the management of non-surgically treated diabetic foot osteomyelitis
Dr Amritava Ghosh3 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年4月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 3
- 主要终点
- Remission of diabetic foot osteomyelitis.
研究概览
简要总结
This study is a randomized, single blind, parallel group, multi-center trial comparing the efficacy and safety of 4 weeks versus 6 weeks antibiotic therapy in 104 patients with non-surgically treated diabetic foot osteomyelitis that will be conducted in three centers in India. The primary outcome measure will be remission of diabetic foot osteomyelitis assessed at 6 months after completion of the antibiotic treatment. The secondary outcome will be adverse events associated with antibiotic therapy at 4 weeks and 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Presence of forefoot diabetic foot osteomyelitis.
- •Patient willing for a follow up of 6 months after completion of the antibiotic treatment.
- •Acceptance of local wound care, off-loading.
排除标准
- •Patients who do not give consent to be included in the study.
- •Pregnant and lactating women.
- •Peripheral arterial disease.
- •Indication for bone resection or amputation.
- •Any concomitant infection requiring systemic antibiotic therapy for more than 10 days.
- •Patient who has received more than 5 days of potentially effective systemic antibiotic therapy and the wound has been clinically improving.
- •Material-related infection.
- •Estimated Glomerular Filtration Rate i.e. eGFR less than 30.
结局指标
主要结局
Remission of diabetic foot osteomyelitis.
时间窗: 6 months after completion of the antibiotic treatment.
次要结局
- Adverse events associated with antibiotic therapy.(4 weeks and 6 weeks)
研究者
Dr Amritava Ghosh
All India Institute of Medical Sciences, Raipur
研究点 (3)
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