PTA-DFS study: design of a randomised controlled trial assessing the effects of early percutaneous transluminal angioplasty on the healing of diabetic foot ulcers in persons with type 2 diabetes

Abstract Background Peripheral arterial disease (PAD) and local infections increase the risk of non-healing diabetic foot ulcers (DFU) and limb amputations but are treatable by percutaneous transluminal angioplasty (PTA), local wound care and antibiotic therapy. The exact time to treat chronic leg artery stenosis (LAS) and the role of microbiome composition in DFU remain unclear. This study aims to assess whether an early PTA within 48 h after diagnosing a LAS offers advantages over standard care. Methods The PTA-DFS Study is a randomised controlled monocentric trial including individuals with T2D and DFU, aged > 18 years with haemodynamically relevant chronic LAS. The primary study endpoint is to investigate the impact of the early PTA within 48 h 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 safety-related cardiac events (MACE) over 12 month post-angioplasty using time-to-event analysis. Additional secondary outcomes are time to complete wound healing, major amputation rate and the need for new revascularization. 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. Data will be collected at baseline, 24 h, 1, 2, 3, 6, and 12 months after PTA. Diabetic kidney disease, distal symmetric polyneuropathy, retinopathy, cardiomyopathy, LAS will be assessed by laboratory analyses, clinical scores, AI-based fundus photography, echocardiography, duplex sonography, and pulse oscillography. Discussion The PTA-DFS aims to improve diagnostic and therapeutic algorithms, risk assessment and enable tailored therapies for persons with T2D and ischemic DFU. Trial registration Trial Registration Number: NCT06124586 (Registration Date: 2023–08-2).