Early versus planned balloon opening of narrowed leg arteries in diabetic foot ulcers
Tests early balloon treatment of narrowed leg arteries in adults with diabetic foot ulcers.
Plain-language title generated from the registry record
Registry title: Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)
Key facts
- Where
- Düsseldorf, GermanySee the site
Where in Germany
- University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular MedicineDüsseldorf, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heinrich-Heine University, Duesseldorf
- Trial code
- NCT06124586
- Record updated
- 4 February 2026
- Original description
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 chronic ischaemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating peripheral arterial disease (PAD) by revascularization in DFU after initial diagnosis is unknown and has yet to be fully understood.Read full original descriptionShow less
Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome
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 chronic ischaemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating peripheral arterial disease (PAD) by revascularization in DFU after initial diagnosis is unknown and has yet to be fully understood.
Inclusion: 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: Treatment with certain drugs (immunosuppressive therapy,; Immunomodulators, chemotherapy, antibiotic therapy < 2 weeks before; Participation in other interventional trials and receipt of investigational medication within the last 30 days; Type 1 diabetes mellitus (GADA, ICA, IA-2A, ZnT8A positive); Diseases of the pancreas; Severe neurological or psychiatric disease; Known presence of malignant tumor disease within the past 5 years; Acute leg ischemia (sudden onset, sensorimotor deficits, pale extremity, pain, loss of pulse, and shock); Minors or subjects incapable of giving consent; Pregnant or breastfeeding women; intervention); Blood or plasma donation within the last 3 months.