Status:
RECRUITING
Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors
Lead Sponsor:
Wroclaw Medical University
Collaborating Sponsors:
Poznan University of Medical Sciences
Military Institute of Medicine National Research Institute
Conditions:
Peripheral Arterial Disease(PAD)
Eligibility:
All Genders
18+ years
Brief Summary
The study is observational and involves patients (pts) with peripheral arterial occlusive disease (PAD) who have undergone lower limb revascularization procedures. Patients who are at least one year p...
Detailed Description
Project Objective: To assess the impact of SGLT2 inhibitors (SGLT2-i) on vascular complications in patients undergoing peripheral revascularization. Specific Objective: To evaluate the incidence of 3...
Eligibility Criteria
Inclusion
- Peripheral vascular procedure ( Conventional surgical procedure or minimally invasive procedure) due to acute or chronic ischemia
- Use of SGLT2 inhibitors (applies only to the group exposed to flozins) for at least 3 months prior to the vascular procedure (the indication for initiating the drug is irrelevant: chronic kidney disease \[CKD\] / cardiac reasons / diabetes), or immediately after the vascular procedure
- Ability to determine the patient's outcomes within a minimum of 30 days up to 1 year following the vascular procedure
Exclusion
- Vascular injury as the reason for the procedure
- Amputation due to causes other than ischemia (e.g., cancer, neuropathy, trauma without coexisting ischemia)
- Planned revascularization procedure other than for the lower limbs at the time of hospital discharge (e.g., coronary or carotid arteries)
- Planned ischemia-related amputation or reoperation of the operated limb at the time of hospital discharge
- Planned other major surgical procedure with high cardiovascular risk at the time of hospital discharge
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07157475
Start Date
July 1 2025
End Date
December 31 2026
Last Update
September 5 2025
Active Locations (1)
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1
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland