Early angioplasty for diabetic foot syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of early percutaneous transluminal angioplasty (PTA) within 48 hours of diagnosis for diabetic foot ulcers compared to standard elective PTA. Participants will be randomly assigned to receive either immediate or elective PTA, with their wound healing monitored using advanced AI-based analysis. The study aims to assess not only the healing of foot ulcers but also the occurrence of major adverse limb and cardiac events over a 12-month period. Data will be collected at multiple time points to evaluate the outcomes of both treatment approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
  Düsseldorf, Germany Recruiting

Study contacts

• Principal investigator: Hans Lucas Busch, MD — Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
• Study coordinator: Hans Lucas Busch, MD
• Email: hanslucas.busch@med.uni-duesseldorf.de
• Phone: +49 (0)211 81 08753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.