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临床试验/NCT04041739
NCT04041739Unknown不适用

The Effect of Fungal Infection on the Outcome Among Diabetic Patients With Foot Osteomyelitis

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
detect magnitude of fungal infection as an etiology causing persistent non healed diabetic foot osteomyelitis

研究概览

简要总结

estimate the percentage of fungal infection in the pathogenesis of diabetic foot osteomyelitis and assess the outcome of patients with fungal diabetic foot osteomyelitis

详细描述

Approximately 60% of diabetic foot ulcers (DFUs) are complicated by infection. In more than two-thirds of the cases, infection is the main cause for major lower limb amputation in diabetic patients with foot ulceration. Infections may complicate DFUs in both neuropathic and ischemic ulcers.

However, the simultaneous presence of peripheral arterial disease (PAD) and infection influence the evolution of DFUs, increasing the risk of non-healing and major amputation.

Osteomyelitis is usually due to non-healing ulcers and it is associated with high risk of major amputation.

Osteomyelitis can affect any bone but most frequently the forefoot (90%), followed by the midfoot (5%) and the hindfoot (5%). Forefoot have a better prognosis than midfoot and hindfoot osteomyelitis. Above the ankle amputation risk is significantly higher for hindfoot (50%), than midfoot (18.5%) and forefoot (0.33%).

The diagnosis of osteomyelitis should be first based on clinical signs of infection supported by laboratory, microbiological and radiological evaluation. However, the diagnosis remains a challenge and DFO is often not recognized easily in its initial phase.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • All diabetic foot ulcers with osteomyelitis

排除标准

  • Patients on corticosteroid therapy.
  • Patients on long term antibiotic therapy.

结局指标

主要结局

detect magnitude of fungal infection as an etiology causing persistent non healed diabetic foot osteomyelitis

时间窗: "through study completion, an average of 2 year".

to evaluate the percentage of fungal infection among foot osteomyelitis and its effect on either healing or amputation.

次要结局

  • detect response of healing of resistant infected osteomyelitis to antifungal therapy(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rowyda El-sayed Gooda Ali

assistant lecturer

Assiut University

研究点 (1)

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