Randomised, controlled, non-inferiority trial comparing narrow versus broad-spectrum antibiotic regimens for mild to moderate diabetic foot infection

South West Sydney Limb Preservation and Wound Research0 个研究点目标入组 340 人开始时间: 2019年8月26日最近更新: 2021年7月21日

试验速览

暂无简介。

•Type 1 or 2 Diabetes mellitus
•- Newly diagnosed (<14 days) infective signs of symptoms
•- No use of topical or systemic antimicrobial/antibiotic therapy 72 hours (3 days) prior to enrolment
•- Mild to moderate Diabetic Foot Infection (PEDIS grade 2-3, IDSA mild or moderate foot infection, WIfI grade 1-2)
•- Wound without bone involvement (Grade 1 and 2)
•- Age >18 years
•- Adequate peripheral vascular supply (good blood flow, measured as grade 0-2 WIfI)

•- Participants with chronic infective symptoms who have received multiple (>2) antibiotic regimens within the previous 4 weeks or greater
•- Proof of underlying bone involvement (osteomyelitis) based on; imaging (plain x-ray, computed tomography [CT], or magnetic resonance imaging [MRI]), clinical examination (exposed bone or positive probe to bone test) or culture/histopathology of bone specimen
•- Diabetic foot ulcer of small size - <2cm in surface area
•- Age under 18 years
•- Documented peripheral arterial disease with either; ankle brachial indices < or equal to 0.4, toe brachial indices <0.5, toe pressure <40mmHg
•- Pregnant women, women desiring pregnancy within the duration of the study, or those unwilling to practice contraception, women who are breastfeeding
•- Stage 4-5 chronic kidney disease and/or an estimated glomerular filtration rate (eGFR) of <30ml/min/m
•- Active liver disease as defined by an INR >2 (in the absence of oral anti-coagulation) and/or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 upper limit of normal (ULN)
•- Chronic liver disease as defined as clinical history of decompensating chronic liver disease (ascites, encephalopathy or variceal bleeding)
•- otherwise assessed by study investigators as unsuitable to take tissue via biopsy or unable to follow trial protocols

发起方

South West Sydney Limb Preservation and Wound Research