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
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