Comparison of Medical and Medical-surgical Management of Diabetic Foot Osteomyelitis
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing
研究概览
简要总结
Osteomyelitis is a frequent complication of diabetic foot ulcer. Several therapeutic strategies are used : medical treatment with antibiotics and foot offloading or surgical treatment consisting in the resection of infected bone and a shorter antibiotic course. The medical treatment risk is a longer healing time and a risk of bone infection relapse. The surgical treatment risk is the ulcer relapse because of the modification of the foot structure. These treatments need to be compared in terms of benefit/risk ratio. Our hypothesis is : 1) in the medical treatment group a 7 month mean healing time of and a 15% osteomyelitis recurrence rate;2) in the medical-surgical treatment group a 4 month mean healing time and a 10% osteomyelitis recurrence rate.
详细描述
The study aim is to compare the rate of therapeutic success of the secondary ostéite with a wound of the foot diabetic, obtained either by a single medical coverage(care), or by a medical surgical coverage(care). The therapeutic success being defined by the association of 1) the absence of local distribution(broadcasting) of the ostéite 2) the healing of the wound 3) in 12 months of the healing the absence of local recurrence of the ostéite
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neuropathy and a forefoot ulcer
- •osteomyelitis on X ray involving one or two contiguous ray
- •confirmed osteomyelitis on bone biopsy if a metatarsal head is involved
- •palpable distal pulses
排除标准
- •glomerular filtration rate < 30ml/min
- •whole bone destruction
- •contra-indication for off loading
- •ASAT or ALAT > three times normal rate
- •immunosuppressive drugs
- •Charcot foot on the concerned foot
- •pregnancy
结局指标
主要结局
no osteomyelitis spreading and wound healing and no osteomyelitis relapse 12 months after wound healing
时间窗: 12 months after healing
次要结局
- amputation rate(before healing)
- healing time(end of study)
- ulcer relapse 12 months after healing(12 months after healing)