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

Recruiting now · Not applicable

Conditions studied: Diabetic Foot, Diabetes Mellitus, Peripheral Arterial Disease, Diabetic Neuropathies, Diabetic Retinopathy, Anemia, Ulcer Foot, Ulcer Ischemic, Diabetic Polyneuropathy

In brief

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.

Key facts

Study ID: NCT06124586
Run by: Heinrich-Heine University, Duesseldorf
People needed: 200
Starts: 2024-02-01
Expected to finish: 2028-11-01
Last updated by the study team: 2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine — Düsseldorf, Germany (enrolling)

Full record on ClinicalTrials.gov

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