Diabetic Foot UlcerNCT02440282
Comparison of Anesthetic Modalities on Hemodynamic Stability and Postoperative Pain in Diabetic Foot Patients Undergoing Minor Lower Extremity Amputation
An observational study of Diabetic Foot Ulcer and Lower Extremity Amputation, run by Yonsei University.
Trial summary
Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the preferred modality of anesthesia. Read more about this study
- Who is it for?
- Ages 29 to 88 years
- Conditions the study is for
- Diabetic Foot Ulcer, Lower Extremity Amputation
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2014
- 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 29 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive 86 diabetic foot patients who underwent minor LEA
Who may be able to join
- diabetic foot patients who underwent minor LEA
Who cannot join
- emergency cases
- patients who underwent major upper or lower extremity amputations
- patients who received general anesthesia following fail regional or spinal anesthesia
- patients who underwent LEA within 1year, and patients who underwent other concomitant surgeries
About this study
Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the preferred modality of anesthesia. The use of sciatic nerve block has recently gained popularity, however, without the supporting evidence of any benefits. This study was to evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative pain in diabetic foot patients undergoing minor LEA.
- Conditions
- Diabetic Foot Ulcer, Lower Extremity Amputation
- Keywords
- patients
- Medical subject headings
- Diabetic Foot
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 |
|---|---|---|
| Group A | patients undergo general anesthesia | |
| Group B | spinal anesthesia | |
| Group C | ultrasound-guided sciatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood pressure
Measured: every ten minutes from preinduction to 30minutes after sugery
Mean blood pressure
Measured: from arrival at recovery room until 20miutes after surgery at recovery room
Heart rate
Measured: every ten minutes from preinduction to 30minutes after sugery
Heart rate
Measured: from arrival at recovery room until 20miutes after surgery at recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJan 2012
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440282
- Sponsor's protocol ID
- 4-2014-1022
- Status last verified
- Jul 2015
- First submitted
- 24 Apr 2015
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anesthetic Modalities on Hemodynamic Stability and Postoperative Pain in Diabetic Foot Patients Undergoing Minor Lower Extremity Amputation
- ClinicalTrials.gov ID
- NCT02440282
- Acronym / sponsor ID
- 4-2014-1022
- Conditions
- Diabetic Foot Ulcer, Lower Extremity Amputation
- Keywords
- patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 May 2015 (estimated)
- 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.
Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the preferred modality of anesthesia. The use of sciatic nerve block has recently gained popularity, however, without the supporting evidence of any benefits. This study was to evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative pain in diabetic foot patients undergoing minor LEA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –patients undergo general anesthesia |
| Group B | – | –spinal anesthesia |
| Group C | – | –ultrasound-guided sciatic nerve block |
Who may qualify
- Ages
- 29 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive 86 diabetic foot patients who underwent minor LEA
Key inclusion criteria (1 listed)
- diabetic foot patients who underwent minor LEA
Key exclusion criteria (4 listed)
- emergency cases
- patients who underwent major upper or lower extremity amputations
- patients who received general anesthesia following fail regional or spinal anesthesia
- patients who underwent LEA within 1year, and patients who underwent other concomitant surgeries
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
Mean blood pressure
Time frame: every ten minutes from preinduction to 30minutes after sugery
Mean blood pressure
Time frame: from arrival at recovery room until 20miutes after surgery at recovery room
Heart rate
Time frame: every ten minutes from preinduction to 30minutes after sugery
Heart rate
Time frame: from arrival at recovery room until 20miutes after surgery at recovery room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer and Lower Extremity Amputation, run by Yonsei University.
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: finished, as of the sponsor's last update on 2 Jul 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean blood pressure (time frame: every ten minutes from preinduction to 30minutes after sugery). The study lists 4 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 2 Jul 2015.