NCT07157475 Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors
| NCT ID | NCT07157475 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wroclaw Medical University |
| Condition | Peripheral Arterial Disease(PAD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-07-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Edyta Sutkowska, Ph.D
STUDY CHAIR
Wroclaw Medical University
Frequently Asked Questions
Who can join the NCT07157475 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease(PAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07157475 currently recruiting?
Yes, NCT07157475 is actively recruiting participants. Contact the research team at edyta.sutkowska@umw.edu.pl for enrollment information.
Where is the NCT07157475 trial being conducted?
This trial is being conducted at Wroclaw, Poland.
Who is sponsoring the NCT07157475 clinical trial?
NCT07157475 is sponsored by Wroclaw Medical University. The principal investigator is Edyta Sutkowska, Ph.D at Wroclaw Medical University. The trial plans to enroll 300 participants.