Acute Limb IschemiaALI-DOAKNCT07888985
Changes in the Etiology of Acute Limb Ischemia in the DOAK Era
An observational study of Acute Limb Ischemia and Anticoagulants, run by University Hospital Augsburg.
Trial summary
This study therefore investigates whether the proportion of embolic acute limb ischemia in patients with atrial fibrillation changed significantly between the pre DOAK era (2006-2010) and the DOAK era (2012-2018) at a university vascular center Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Limb Ischemia, Anticoagulants
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Oct 2028
- 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: All patients with acute limb ischemia and atrial fibrillation.
Who may be able to join
- Acute Limb Ischemia
- atrial fibrillation
Who cannot join
- aortic dissection
- iatrogenic ALI
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Changes in the Etiology of Acute Limb Ischemia in the DOAK Era - A Retrospective, Single-Center Cohort Study at Augsburg University Hospital
This study therefore investigates whether the proportion of embolic acute limb ischemia in patients with atrial fibrillation changed significantly between the pre DOAK era (2006-2010) and the DOAK era (2012-2018) at a university vascular center
Read the detailed description
Retrospective data analysis of patients with acute limb ischemia and the change of etiology in the era of DOAK. The ICD includes both etiologies as embolic and thrombotic. Therefore recent analysis covered both etiologies as it's not possible to distinguish using ICD only. Aim of the study is a selection of those two etiologies.
- Conditions
- Acute Limb Ischemia, Anticoagulants
- Keywords
- ALI, DOAK, acute limb ischemia, etiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALI with Anticoagulants | Patients suffering form acute limb ischemia medicated with anticogulants | |
| ALI without Anticoagulants | Patients suffering form acute limb ischemia medicated without anticogulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute limb ischemia
number of ALI patients. Method of measurement: Counting numbers, source: ICD-codes.
Measured: 01/2006 till 12/2018
Secondary outcomes (1)
etiology
etiology of acute ischemia, either thrombotic or embolic. Method of measurement: manual selection of ICD-codes
Measured: 01/2006 till 12/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Limb IschemiaStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvonne Gosslau, University Hospital Augsburg
- Investigators
- Yvonne N Goßlau, MD, PhD, Principal investigator, Vascular Surgery, Faculty of Medicine, University of Augsburg, Stenglinstr. 2, 86165 Augsburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888985
- Sponsor's protocol ID
- ALI-DOAK
- Other IDs
- 26-0826
- Acronym
- ALI-DOAK
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: retrospective analysis
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Etiology of Acute Limb Ischemia in the DOAK Era - A Retrospective, Single-Center Cohort Study at Augsburg University Hospital
- ClinicalTrials.gov ID
- NCT07888985
- Acronym / sponsor ID
- ALI-DOAK / ALI-DOAK
- Conditions
- Acute Limb Ischemia, Anticoagulants
- Keywords
- ALI, DOAK, acute limb ischemia, etiology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 22 Oct 2026 (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.
This study therefore investigates whether the proportion of embolic acute limb ischemia in patients with atrial fibrillation changed significantly between the pre DOAK era (2006-2010) and the DOAK era (2012-2018) at a university vascular center
Detailed description
Retrospective data analysis of patients with acute limb ischemia and the change of etiology in the era of DOAK. The ICD includes both etiologies as embolic and thrombotic. Therefore recent analysis covered both etiologies as it's not possible to distinguish using ICD only. Aim of the study is a selection of those two etiologies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALI with Anticoagulants | – | –Patients suffering form acute limb ischemia medicated with anticogulants |
| ALI without Anticoagulants | – | –Patients suffering form acute limb ischemia medicated without anticogulants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with acute limb ischemia and atrial fibrillation.
Key inclusion criteria (2 listed)
- Acute Limb Ischemia
- atrial fibrillation
Key exclusion criteria (2 listed)
- aortic dissection
- iatrogenic ALI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
acute limb ischemia
Time frame: 01/2006 till 12/2018
number of ALI patients. Method of measurement: Counting numbers, source: ICD-codes.
1 secondary outcome
etiology
Time frame: 01/2006 till 12/2018
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 22 Oct 2026.
- Individual participant dataSharing planned: No. retrospective analysis
Related trials for Acute Limb Ischemia
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Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
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Recruiting
The ArtixASCEND Study
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Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
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A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)
Lower Extremity Acute Limb Ischemia, LE ALI
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.
Yvonne N Goßlau, MD, PhD principal investigator
Vascular Surgery, Faculty of Medicine, University of Augsburg, Stenglinstr. 2, 86165 Augsburg, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Limb Ischemia and Anticoagulants, run by University Hospital Augsburg.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yvonne N Goßlau (+49 821400161977, yvonne.gosslau@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute limb ischemia (time frame: 01/2006 till 12/2018). 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 22 Oct 2026.