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 sites340 target enrollmentAugust 26, 2019

Overview

No summary available.

Registry

who.int

Start Date

August 26, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

South West Sydney Limb Preservation and Wound Research

•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