Status:
RECRUITING
Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
German Diabetes Center
Conditions:
Diabetic Foot
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
The planned study is a monocentric, randomized, and controlled clinical trial. Study participants will be randomized in a 1:1 ratio into two groups: one receiving early PTA ("immediate PTA", within 48...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06124586
Start Date
February 1 2024
End Date
November 1 2028
Last Update
December 12 2024
Active Locations (1)
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1
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, Germany, 40225