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

Launched by HEINRICH-HEINE UNIVERSITY, DUESSELDORF · Nov 8, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome" (PTA-DFS) is investigating whether treating foot problems in people with diabetes right away (within 48 hours) is better than standard care, which can take longer. The study focuses on patients with diabetic foot ulcers and aims to see if early treatment improves healing, reduces infection rates, and lowers the chances of needing an amputation or facing serious complications related to their heart or blood vessels. Researchers are also interested in how this treatment might affect the bacteria found in foot wounds, which can play a role in infections.

To participate in this trial, individuals must be adults over 18 years old with Type 2 diabetes and specific foot ulcers that don't require immediate surgery. They should also have controlled blood sugar levels. However, certain groups, such as those with severe leg pain or other serious health conditions, won't be eligible. Participants can expect close monitoring during the study and will help researchers learn more about the best timing and methods for treating foot problems in people with diabetes.

Gender

ALL

Eligibility 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