Actively Recruiting

Age: 18Years +
All Genders
ID07157475

Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization and the Impact of SGLT-2 Inhibitors

Led by Wroclaw Medical University · Updated on 2026-03-23

300

Participants Needed

1

Research Sites

N/A

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

This research aims to assess how sodium-glucose co-transporter 2 inhibitors (SGLT2-i) affect vascular complications in patients with peripheral arterial disease (PAD) who have undergone lower limb revascularization procedures. The study compares patients who were treated with SGLT2 inhibitors during the year after surgery to those who were not, focusing on cardiovascular and limb-related events. It is an observational study conducted by Wroclaw Medical University, monitoring outcomes over one year. Patients included are those who had either open or minimally invasive vascular surgery for acute or chronic ischemia. The study observes two groups: those treated with SGLT2 inhibitors such as empagliflozin, dapagliflozin, or canagliflozin during the 12 months following the procedure, and those who did not receive these medications. Treatment is not assigned by the study but occurs as part of routine care. The observation period includes assessments at 30 days, 3 months, and 1 year post-procedure. Participants are contacted by phone to report any major adverse cardiovascular events (MACE) like heart attacks, strokes, or cardiovascular death, and major adverse limb events (MALE) such as vessel restenosis, reinterventions, or amputations. Demographic and clinical data are collected from medical records. Researchers compare the number of these events between the treated and untreated groups during the year following surgery to better understand the impact of SGLT2 inhibitors on vascular outcomes.

CONDITIONS

Brief Title

Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who underwent a peripheral vascular procedure (either conventional surgical or minimally invasive) due to acute or chronic ischemia
  • Use of SGLT2 inhibitors for at least 3 months prior to or immediately after the vascular procedure (only for the treated group)
  • Ability to determine patient outcomes between 30 days and 1 year following the vascular procedure
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Vascular injury as the cause of the procedure
  • Amputation due to causes other than ischemia, such as cancer, neuropathy, or trauma without ischemia
  • Planned revascularization procedures for arteries other than lower limbs at hospital discharge
  • Planned ischemia-related amputation or reoperation of the operated limb at hospital discharge
  • Planned major surgical procedure with high cardiovascular risk at hospital discharge

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Observation

Duration - 1 year

Participants who have undergone peripheral vascular surgery are observed for vascular complications and major adverse events during the one-year follow-up period.

Assessments at 30 days, 3 months, and 1 year post-procedure

Trial Site Locations

Total: 1 location

1

Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, Poland

Actively Recruiting

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Research Team

E

Edyta Sutkowska, M.D., Ph.D.

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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