Peripheral Arterial Disease(PAD)NCT07157475
Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors
An observational study of Peripheral Arterial Disease(PAD), run by Wroclaw Medical University at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease(PAD)
- What is being tested?
- Treatment with SGLT2 inhibitors (flozins)
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The analyzed cases will involve patients from three major vascular clinics located in Wrocław, Poznań, and Warsaw.
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship
Edyta Sutkowska, M.D., PH.D., 48503077016, edyta.sutkowska@umw.edu.pl
About this study
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
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.
Read the 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-point MACE* (Major Adverse Cardiac Events) and MALE** (Major Adverse Limb Events) following vascular surgical procedures (both open and minimally invasive), performed in patients treated with SGLT2- i vs controls ( non-treated pts).
Observation Period: One year - assessment at 30 days, 3 months, and 1 year post-procedure.
Definitions for:
- MACE = Non-fatal myocardial infarction (MI),Non-fatal stroke involving the central nervous system (CNS), Cardiovascular death
** MALE = Untreated restenosis or deterioration in patency of a previously revascularized vessel , Reintervention in the revascularized segment due to impaired patency, Amputation (either above or below the knee) of the revascularized limb.
Demographic and clinical data will be obtained from the medical records of patients hospitalized in three vascular surgery departments (Wrocław, Poznań, Warsaw), while information regarding MACE , MALE, and the use of SGLT2-i will be collected via telephone interviews with the patients (or their family members, if the patient is deceased).
The number of MACE and MALE incidents during the year following the procedure will be compared between the two groups.
- Conditions
- Peripheral Arterial Disease(PAD)
- Being tested
- Treatment with SGLT2 inhibitors (flozins)
- Keywords
- flozins, SGLT2i, peripheral arterial disease, revascularisation, MACE, MALE
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with SGLT2 inhibitors (flozins)Drug
Patients received SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin) as part of their routine clinical care during the 12-month follow-up period after elective or urgent lower limb revascularization procedures. The study does not assign treatment; medication use occurred independently of the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE
MACE is defined as a composite of : Non-fatal myocardial infarction (MI); Non-fatal stroke involving the central nervous system (CNS); or Cardiovascular death MALE is defined as a composite of : Untreated loss or deterioration of patency in a previously revascularized vessel; Repeat intervention in a revascularized segment due to impaired patency, or Amputation (above or below the knee) of the revascularized limb Unit of Measure: Number of participants with at least one event
Measured: 12 months from the vascular intervention
Secondary outcomes (6)
Non-fatal Myocardial Infarction (MI)
Non-fatal myocardial infarction (MI), Unit of Measure: Number of participants
Non-fatal stroke involving the central nervous system (CNS)
Cardiovascular death
Untreated loss or deterioration of patency in a previously revascularized vessel
Repeat intervention in a revascularized segment due to impaired patency
Amputation (above or below the knee) of the revascularized limb
Measured: 12 months from the vascular intervention
Non-fatal Stroke Involving the Central Nervous System (CNS)
Non-fatal Stroke Involving the Central Nervous System (CNS), Unit of Measure: Number of participants
Measured: 12 months from the vascular intervention
Cardiovascular Death
Cardiovascular Death, Unit of Measure: Number of participants
Measured: 12 months from the vascular intervention
Loss or Deterioration of Patency in a Previously Revascularized Vessel
Loss or Deterioration of Patency in a Previously Revascularized Vessel, Unit of Measure: Number of participants
Measured: 12 months from the vascular intervention
Repeat intervention in a revascularized segment due to impaired patency
Repeat intervention in a revascularized segment due to impaired patency; Unit of Measure: Number of participants and number of limbs
Measured: 12 months from the vascular intervention
Amputation of the revascularized limb
Amputation (above or below the knee) of the revascularized limb; Unit of Measure: Number of participants and number of limbs
Measured: 12 months from the vascular intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease(PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences, Military Institute od Medicine National Research Institute
- Responsible party
- Principal investigator, Edyta Sutkowska, Wroclaw Medical University
- Investigators
- Edyta Sutkowska, Ph.D, Study chair, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157475
- Sponsor's protocol ID
- BW-24/2025
- Status last verified
- Mar 2026
- First submitted
- 18 Aug 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07157475
- Acronym / sponsor ID
- BW-24/2025
- Conditions
- Peripheral Arterial Disease(PAD)
- Keywords
- flozins, SGLT2i, peripheral arterial disease, revascularisation, MACE, MALE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences, Military Institute od Medicine National Research Institute
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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-point MACE* (Major Adverse Cardiac Events) and MALE** (Major Adverse Limb Events) following vascular surgical procedures (both open and minimally invasive), performed in patients treated with SGLT2- i vs controls ( non-treated pts).
Observation Period: One year - assessment at 30 days, 3 months, and 1 year post-procedure.
Definitions for:
- MACE = Non-fatal myocardial infarction (MI),Non-fatal stroke involving the central nervous system (CNS), Cardiovascular death
** MALE = Untreated restenosis or deterioration in patency of a previously revascularized vessel , Reintervention in the revascularized segment due to impaired patency, Amputation (either above or below the knee) of the revascularized limb.
Demographic and clinical data will be obtained from the medical records of patients hospitalized in three vascular surgery departments (Wrocław, Poznań, Warsaw), while information regarding MACE , MALE, and the use of SGLT2-i will be collected via telephone interviews with the patients (or their family members, if the patient is deceased).
The number of MACE and MALE incidents during the year following the procedure will be compared between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients after vascular surgery treated with flozins | – | Drug: Treatment with SGLT2 inhibitors (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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The analyzed cases will involve patients from three major vascular clinics located in Wrocław, Poznań, and Warsaw.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with SGLT2 inhibitors (flozins)Patients received SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin) as part of their routine clinical care during the 12-month follow-up period after elective or urgent lower limb revascularization procedures. The study does not assign treatment; medication use occurred independently of the study protocol. | Drug | Patients after vascular surgery treated with flozins |
Primary outcome
MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE
Time frame: 12 months from the vascular intervention
MACE is defined as a composite of : Non-fatal myocardial infarction (MI); Non-fatal stroke involving the central nervous system (CNS); or Cardiovascular death MALE is defined as a composite of : Untreated loss or deterioration of patency in a previously revascularized vessel; Repeat intervention in a revascularized segment due to impaired patency, or Amputation (above or below the knee) of the revascularized limb Unit of Measure: Number of participants with at least one event
6 secondary outcomes
Non-fatal Myocardial Infarction (MI)
Time frame: 12 months from the vascular intervention
Non-fatal Stroke Involving the Central Nervous System (CNS)
Time frame: 12 months from the vascular intervention
Cardiovascular Death
Time frame: 12 months from the vascular intervention
Loss or Deterioration of Patency in a Previously Revascularized Vessel
Time frame: 12 months from the vascular intervention
Repeat intervention in a revascularized segment due to impaired patency
Time frame: 12 months from the vascular intervention
Amputation of the revascularized limb
Time frame: 12 months from the vascular intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
Related trials for Peripheral Arterial Disease(PAD)
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edyta Sutkowska, Ph.D study chair
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease(PAD), run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edyta Sutkowska, M.D., Ph.D. (48503077016, edyta.sutkowska@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (Major Adverse Cardiovascular Events) and MALE (Major Adverse Limb Events)-Number of Participants Experiencing MACEor MALE (time frame: 12 months from the vascular intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.