Early versus Standard Percutaneous Transluminal Angioplasty for Healing Diabetic Foot Ulcers in Type 2 Diabetes Patients and Its Impact on Wound Microbial Changes

What this Trial Is About

Researchers are evaluating whether performing early angiography and percutaneous transluminal angioplasty PTA within 48 hours after diagnosing a flow-limiting leg artery stenosis offers benefits over the current standard of care, which involves an elective PTA procedure within 6 weeks. The study focuses on patients with type 2 diabetes who have diabetic foot ulcers and peripheral arterial disease. It aims to understand the effects of early PTA on wound healing and the dynamics of the wound microbiome, as well as its impact on major adverse limb and cardiac events over a year. Participants are randomly assigned to one of two groups those receiving early PTA within 48 hours and those undergoing elective PTA within 6 weeks following international guidelines. Both groups receive the same baseline and follow-up assessments except for the timing of PTA. If wound healing complications arise in the elective group, participants may switch to immediate PTA. The study includes extensive monitoring of foot ulcers using 3D AI-based wound analysis, vascular assessments, microbiome sequencing, and blood tests, along with evaluation of diabetic complications like neuropathy, retinopathy, and kidney disease. Throughout the 12-month study period, participants attend scheduled visits for clinical evaluations, wound documentation, imaging, blood sampling, and interviews about vascular events and overall health. Researchers measure wound area changes, monitor adverse limb and cardiac events, analyze wound microbiome changes, and assess oxygen levels in the wound area. Safety and treatment effects are carefully tracked, with data analyzed separately by clinicians and data analysts to reduce bias. The study aims to recruit about 200 participants and will use advanced statistical methods to assess outcomes.

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