Actively Recruiting
Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors
Led by Wroclaw Medical University · Updated on 2026-03-23
300
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
W
Wroclaw Medical University
Lead Sponsor
P
Poznan University of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 post-procedure will be contacted by phone and asked whether any cardiovascular complications occurred during that period, specifically major adverse cardiovascular events (MACE) or major adverse limb events (MALE), and whether they had been taking sodium-glucose co-transporter 2 inhibitors (SGLT2-i, "flozins") during the year following the procedure. The results from the group of pts who, for any reason, received SGLT2-i treatment after the vascular procedure (including those who had initiated treatment before surgery) will be compared to the results from the group of patients who did not receive such treatment, with regard to the occurrence of the aforementioned complications.
CONDITIONS
Official Title
Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Underwent a peripheral vascular procedure (either conventional surgery or minimally invasive) due to acute or chronic ischemia
- Treated with SGLT2 inhibitors for at least 3 months before or immediately after the vascular procedure (regardless of treatment reason)
- Able to determine health outcomes from at least 30 days to 1 year following the vascular procedure
You will not qualify if you...
- Vascular injury caused the procedure
- Amputation caused by reasons other than ischemia (such as cancer, neuropathy, or trauma without ischemia)
- Planned revascularization procedures on arteries other than the lower limbs at hospital discharge
- Planned ischemia-related amputation or reoperation on the operated limb at hospital discharge
- Planned other major surgical procedures with high cardiovascular risk at hospital discharge
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland
Actively Recruiting
Research Team
E
Edyta Sutkowska, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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