WOUNDSinCLTI Trial Update: Pathogen-Driven Insights Into Limb Salvage in CLTI
Universitaets-Herzzentrum Freiburg, Bad Krozingen, Germany
On the first day of AMP 2025, Thomas Zeller, MD, from the Universitaets-Herzzentrum Freiburg, Bad Krozingen, Germany, presented the inaugural findings from the WOUND infection and clinical outcomeS IN patients with Chronic Limb-Threatening Ischemia (WOUNDSinCLTI) study, a prospective multicenter cohort designed to explain how specific wound pathogens influence revascularization outcomes in patients with advanced peripheral arterial disease (PAD). Against a backdrop of rising diabetes, dialysis dependency, and complex foot infections in CLTI, this trial seeks to refine empiric antimicrobial strategies and ultimately improve limb salvage and survival.
Foot infections in CLTI not only double the risk of amputation but also indicate higher mortality, yet they remain understudied. Prior registry analyses have highlighted key hazards following endovascular therapy (EVT): gram-negative bacteria, diabetes mellitus, dialysis dependency, and severe WIfI infection, underscoring the need for pathogen-focused outcome research.
WOUNDSinCLTI will enroll 640 PAD patients with Rutherford category 5 to 6 and clinically infected leg ulcers undergoing either endovascular or surgical revascularization. The primary objectives include cataloguing bacterial patterns and correlating specific pathogens with major vs minor amputation rates, post-procedural bloodstream infection, and overall and infection-related mortality. Secondary objectives expand to mapping antimicrobial resistance, assessing the microbiological efficacy of empirical antibiotic regimens, evaluating wound-healing kinetics, and exploring socioeconomic influences on amputation and healing outcomes.
Initiated in May 2025 at Universitäts-HerzzentrumiFreiburg in Bad Krozingen, the trial will roll out across eleven additional European centers, including Lugano, Leipzig, Graz, and London, capturing regional variations in pathogen prevalence and resistance profiles. Rigorous inclusion criteria focus on adult CLTI patients with WIfI-classified infected ulcers; exclusions apply to minors, pregnant patients, and those without consent.
