Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors
Key facts
- Who runs it
- Wroclaw Medical University
- Where
- Poland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 300 people, planned
- Started
- 1 Jul 2025
- Expected to end
- 31 Dec 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- Treatment with SGLT2 inhibitors (flozins)
- Record updated
- 23 March 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Planned other major surgical procedure with high cardiovascular risk at the time of hospital discharge
- Amputation due to causes other than ischemia (e.g., cancer, neuropathy, trauma without coexisting ischemia)
- Vascular injury as the reason for the procedure
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Patients after vascular surgery treated with flozins
Patients aged ≥18 years who have undergone vascular surgery (either open or minimally invasive procedures) and, for any reason, were treated with SGLT2 inhibitors ("flozins") during the one-year follow-up period after the procedure.
Treatment: Treatment with SGLT2 inhibitors (flozins)
- Patients after vascular surgery with no exposure to flozins (controls)
Patients aged ≥18 years who have undergone vascular surgery (either open or minimally invasive procedures) and were not exposed to SGLT2 inhibitors ("flozins") during the one-year follow-up period after the procedure.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Ocena powikłań Naczyniowych u pacjentów Poddanych Rewaskularyzacji Obwodowej: wpływ inhibitorów SGLT-2 The Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors
- Record updated
- 23 March 2026