Daibetic FootNCT05012059
A Comparison of General Versus Peripheral Nerve Block for Lower Extremity Amputation in Diabetic Patients With Bleeding Tendency: a Retrospective Study
An observational study of Daibetic Foot, run by Yonsei University at 1 site in South Korea.
Trial summary
Retrospective data collection. The aim of this study is to compare general anesthesia and nerve block anesthesia with respect to the postoperative complications in patients undergoing diabetic leg amputation and having bleeding tendency. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Daibetic Foot
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2021to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients ≥20 years who underwent lower extremity amputation for diabetic foot under general anesthesia or PNB and having coagulopathy in which condition that neuraxial block is contraindicated
Who may be able to join
- 1.Adults patients ≥20 years who underwent lower extremity amputation for diabetic foot under general anesthesia or PNB and having coagulopathy in which condition that neuraxial block is contraindicated
Who cannot join
- patients with prior surgical history within 1 month
- combined operation (joint operation)
- patients who required continuous intravenous administration of vasopressors and/or mechanical ventilation prior to surgery
- combination of general anesthesia and PNB
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 120-749
Hye Jin Kim, MD, 82-2-2224-4464, jackiedi@yuhs.ac
About this study
Retrospective data collection. The aim of this study is to compare general anesthesia and nerve block anesthesia with respect to the postoperative complications in patients undergoing diabetic leg amputation and having bleeding tendency.
- Conditions
- Daibetic Foot
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of major complication
Major complications included pneumonia (followed the definition of European Perioperative Clinical Outcome), myocardial infarction (followed the definition of World Health Organization), stroke (A central neurologic deficit persisting postoperatively for > 24 h), venous thromboembolism (confirmed by image study), delirium (confirmed by psychiatrist), acute kidney injury (based on Kidney Disease: Improving Global Outcomes Criteria), new requirement for dialysis, surgical site infection, Return to the OP room.
Measured: Within 1 month after the surgery
Occurrence of mortality
Mortality refers all deaths.
Measured: Within 1 month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study startAug 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Daibetic FootStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hye Jin Kim, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012059
- Sponsor's protocol ID
- 4-2021-0378
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of General Versus Peripheral Nerve Block for Lower Extremity Amputation in Diabetic Patients With Bleeding Tendency: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05012059
- Acronym / sponsor ID
- 4-2021-0378
- Conditions
- Daibetic Foot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 19 Aug 2021 (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.
Retrospective data collection. The aim of this study is to compare general anesthesia and nerve block anesthesia with respect to the postoperative complications in patients undergoing diabetic leg amputation and having bleeding tendency.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients ≥20 years who underwent lower extremity amputation for diabetic foot under general anesthesia or PNB and having coagulopathy in which condition that neuraxial block is contraindicated
Key inclusion criteria (1 listed)
- 1.Adults patients ≥20 years who underwent lower extremity amputation for diabetic foot under general anesthesia or PNB and having coagulopathy in which condition that neuraxial block is contraindicated
Key exclusion criteria (4 listed)
- patients with prior surgical history within 1 month
- combined operation (joint operation)
- patients who required continuous intravenous administration of vasopressors and/or mechanical ventilation prior to surgery
- combination of general anesthesia and PNB
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
Occurrence of major complication
Time frame: Within 1 month after the surgery
Major complications included pneumonia (followed the definition of European Perioperative Clinical Outcome), myocardial infarction (followed the definition of World Health Organization), stroke (A central neurologic deficit persisting postoperatively for > 24 h), venous thromboembolism (confirmed by image study), delirium (confirmed by psychiatrist), acute kidney injury (based on Kidney Disease: Improving Global Outcomes Criteria), new requirement for dialysis, surgical site infection, Return to the OP room.
Occurrence of mortality
Time frame: Within 1 month after the surgery
Mortality refers all deaths.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Hye Jin Kim principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
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 Daibetic Foot, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Aug 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hye Jin Kim (82-2-2224-4464, jackiedi@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of major complication (time frame: Within 1 month after the surgery). The study lists 2 primary outcomes in all. 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 19 Aug 2021.