arrow versus broad antibiotic treatment for diabetic foot infections (NvB-DFI)

Phase 4

Recruiting

• Conditions: Diabetic foot infection; Infection - Studies of infection and infectious agents; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12619001190190
• Lead Sponsor: South West Sydney Limb Preservation and Wound Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-26
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

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)

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified