Actively Recruiting
Led by Heinrich-Heine University, Duesseldorf · Updated on 2026-02-04
200
Participants Needed
1
Research Sites
39 weeks
Total Duration
H
Heinrich-Heine University, Duesseldorf
Lead Sponsor
G
German Diabetes Center
Collaborating Sponsor
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.
CONDITIONS
Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive percutaneous transluminal angioplasty (PTA) of the leg either early within 48 hours or electively within 6 weeks after diagnosis of a flow-limiting leg artery stenosis, followed by clinical evaluations focusing on wound healing and overall health.
1 to 2 PTA procedures depending on group assignment
Duration - 12 months
Participants undergo regular follow-up visits to monitor wound healing progress, vascular events, and overall health for up to 12 months after PTA, including wound documentation, blood collection, and interviews to assess complications.
Visits at baseline, day 1, and at 1, 2, 3, 6, and 12 months post-PTA
Total: 1 location
1
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, Germany, 40225
Actively Recruiting
H
Hans Lucas Busch, MD
L
Lisa Dannenberg, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Kálmán B Bódis, David-Ioan Florea, Shouheng Goh...
https://pubmed.ncbi.nlm.nih.gov/41239210