Early angioplasty for diabetic foot syndrome
Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome
This study is testing if getting a quick angioplasty after being diagnosed with diabetic foot ulcers helps heal the wounds better than waiting for the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Düsseldorf) |
| Trial ID | NCT06124586 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with type 2 diabetes and foot ulcers who meet specific clinical criteria.
Not a fit: Patients with acute leg ischemia, type 1 diabetes, or severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve wound healing and reduce complications for patients with diabetic foot syndrome.
How similar studies have performed: While similar studies have explored angioplasty for diabetic foot ulcers, this specific early intervention approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Düsseldorf
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.