Condition: Diabetic Foot · Diabetes Mellitus · Peripheral Arterial Disease · Sponsor: Heinrich-Heine University, Duesseldorf
The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in percutaneous transluminal angioplasty (PTA) readiness ("immediate" treatment, within 48h) has advantages over the "standard of care", i.e., an elective procedure ("elective PTA") for the treatment of diabetic foot ulcer (DFU). The primary study endpoint is to investigate the impact of the "early PTA" within 48 hours on wound-healing assessed by wound area changes after PTA using a 3D-camera with artificial intelligence (AI)-based wound-analysis-system. The secondary endpoint is the effect of early PTA on the combined occurrence of major adverse limb (MALE) and cardiac events (MACE) over 12 months post-angioplasty using time-to-event analysis. Data will be collected at baseline, 24 hours, 1, 2, 3, 6, and 12 months after PTA. Diabetic kidney disease, distal symmetric polyneuropathy, retinopathy, cardiomyopathy, laboratory analyses, clinical scores, AI-based fundus photography, echocardiography, duplex sonography, and pulse oscillography will be assessed. Explanatory variables for wound healing are wound microbiome changes using whole-genome sequencing and oxygen saturation of the wound environment measured using near-infrared spectroscopy. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chr…
This description comes directly from the study's public registry record.
Hans Lucas Busch, MD · +49 (0)211 81 08753 · hanslucas.busch@med.uni-duesseldorf.de
Lisa Dannenberg, MD · +492118105315 · lisa.dannenberg@med.uni-duesseldorf.de
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| University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine | Düsseldorf, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06124586