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Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)

RecruitingNAAges 18 Years - anyAllHeinrich-Heine University, Duesseldorf
NCT06124586 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * volunteer adults * written informed consent * presence of known manifest T2D and fulfilment of the following criteria: * HbA1c \< 10% * presence of pAVD with fulfillment of the following criteria: * PAD Stage After Fontaine IV (foot ulcer) * Presence of foot ulcer with fulfillment of the following criteria: * Foot ulceration without indication for emergency surgical care from stage Wagner 1. * Age \>18 years Exclusion Criteria: * Acute leg ischemia (sudden onset, sensorimotor deficits, pale extremity, pain, loss of pulse, and shock). * Type 1 diabetes mellitus (GADA, ICA, IA-2A, ZnT8A positive). * Minors or subjects incapable of giving consent * Pregnant or breastfeeding women * Treatment with certain drugs (immunosuppressive therapy, * Immunomodulators, chemotherapy, antibiotic therapy \< 2 weeks before * intervention) * Diseases of the pancreas * Severe neurological or psychiatric disease * Known presence of malignant tumor disease within the past 5 years * Participation in other interventional trials and receipt of investigational medication within the last 30 days * Blood or plasma donation within the last 3 months
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What it tests

  • Percutaneous transluminal angioplasty
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Where

1 site
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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