DiabetesNCT03027219
Blood Flow Change After Free Flap Surgery in Diabetic Patients
An observational study of Diabetes, run by Asan Medical Center at 1 site in South Korea.
Trial summary
We aim to evaluate the flow change of arterial anastomosis site during free flap surgery in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Alprostadil
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jan 2017to 29 Nov 2018
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients who are undergoing free flap surgery
Who may be able to join
- Plan to receive free flap transfer under general anesthesia
- Age: >=18 and <80 years old
- History of diabetes mellitus
- Administration of alprostadil during surgery
- Volunteer, who are provided written informed consent prior to study participation
Who cannot join
- Refuse the participation of study
- >= American society of anesthesiologist physical status IV
- Use of any vasopressor or inotropic for hemodynamic instability before participation of study
- Inappropriate subjects who are identified by researchers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study of the Changes of Blood Flow of Arterial Anastomosis-site of Free Flap in Diabetic Patients Who Undergoing Free Flap Transfer
We aim to evaluate the flow change of arterial anastomosis site during free flap surgery in diabetic patients.
Read the detailed description
Objective: flow change of arterial anastomosis site during free flap surgery in diabetic patients.
Background: No research was published about flow change of arterial anastomosis site of the free flap during surgery.
Plan: Using Duplex sonography, various parameters related flap perfusion will be evaluated before and after the administration of alprostadil.
- Conditions
- Diabetes
- Being tested
- Alprostadil
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprostadilDrug
Also called Eglandin
Vasodilator for anastomosis-site of free flap
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow change
Peak velocity of anastomosis-site of free flap
Measured: before alprostadil administration, 30 mins after alprostadil administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start31 Jan 2017
- Primary completion2 Nov 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, Asan Medical Center
- Investigators
- Young-kug Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027219
- Sponsor's protocol ID
- S2016-2043-0003
- Status last verified
- Nov 2018
- First submitted
- 18 Jan 2017
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of the Changes of Blood Flow of Arterial Anastomosis-site of Free Flap in Diabetic Patients Who Undergoing Free Flap Transfer
- ClinicalTrials.gov ID
- NCT03027219
- Acronym / sponsor ID
- S2016-2043-0003
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 23 Jan 2017 (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.
We aim to evaluate the flow change of arterial anastomosis site during free flap surgery in diabetic patients.
Detailed description
Objective: flow change of arterial anastomosis site during free flap surgery in diabetic patients.
Background: No research was published about flow change of arterial anastomosis site of the free flap during surgery.
Plan: Using Duplex sonography, various parameters related flap perfusion will be evaluated before and after the administration of alprostadil.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients who are undergoing free flap surgery
Key inclusion criteria (5 listed)
- Plan to receive free flap transfer under general anesthesia
- Age: >=18 and <80 years old
- History of diabetes mellitus
- Administration of alprostadil during surgery
- Volunteer, who are provided written informed consent prior to study participation
Key exclusion criteria (4 listed)
- Refuse the participation of study
- >= American society of anesthesiologist physical status IV
- Use of any vasopressor or inotropic for hemodynamic instability before participation of study
- Inappropriate subjects who are identified by researchers
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 |
|---|---|---|
| AlprostadilAlso: EglandinVasodilator for anastomosis-site of free flap | Drug | – |
Primary outcome
Flow change
Time frame: before alprostadil administration, 30 mins after alprostadil administration
Peak velocity of anastomosis-site of free flap
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 30 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Young-kug Kim, MD, PhD principal investigator
Asan Medical Center
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 Diabetes, run by Asan Medical Center 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 5 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 30 Nov 2018. 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?
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?
Flow change (time frame: before alprostadil administration, 30 mins after alprostadil administration). 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 30 Nov 2018.