Physiologic Venous DilationNCT07810192
Randomized Assessor-Masked Trial of Moderate Graduated Compression Stockings for Popliteal Vein Dilation During Long-Haul Economy-Class Air Travel After Aesthetic Surgery
A study testing Enoxaparine, Knee-High Graduated Compression Stockings and Standardized Bilateral Popliteal Vein Ultrasound in people with Physiologic Venous Dilation and Air Travel, run by Research Inc at 1 site in Colombia.
Trial summary
This randomized assessor-masked trial will evaluate whether knee-high moderate graduated compression stockings reduce popliteal vein dilation during long-haul economy-class air travel to Bogota. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Physiologic Venous Dilation, Air Travel
- What is being tested?
- Enoxaparine, Knee-High Graduated Compression Stockings and Standardized Bilateral Popliteal Vein Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2024to 1 Dec 2026
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years.
- Economy-class commercial itinerary to Bogota with at least 4 hours of total airborne time.
- No clinical indication that mandates or prohibits compression stockings.
- Ability to obtain the assigned stocking before boarding and wear it as instructed.
- Standardized preflight and postarrival ultrasounds completed before surgery.
- Written informed consent.
Who cannot join
- Current deep venous thrombosis, therapeutic anticoagulation, or severe peripheral arterial disease.
- Significant lower-limb skin disease, ulceration, neuropathy, or deformity preventing safe stocking use.
- Pregnancy.
- Planned use of another compression device during the flight.
- Surgery or major intravenous fluid therapy before completion of the 48-hour examination.
- Inability to complete preflight ultrasound or follow assigned treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Clinica INO
Bogotá
hugo Aguilar, MD, Plastic surgeon, +57 3016918526, havplasticacademy@gmail.com
About this study
This randomized assessor-masked trial will evaluate whether knee-high moderate graduated compression stockings reduce popliteal vein dilation during long-haul economy-class air travel to Bogota. Participants will be assigned to stockings or no stockings and will undergo bilateral ultrasound before flight, within 2 hours after arrival, and at 24 and 48 hours. The primary outcome is the between-group difference in change in mean bilateral popliteal vein diameter from preflight baseline to arrival.
Read the detailed description
Eligible economy-class travelers will be randomized before departure. The intervention group will wear properly fitted knee-high graduated compression stockings from approximately 1 hour before boarding through the arrival ultrasound; the control group will not use lower-limb compression. A masked ultrasound assessor will obtain standardized bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours. Adherence, movement, hydration, symptoms, and skin effects will be recorded. Intention-to-treat mixed models will estimate immediate and persistent treatment effects.
- Conditions
- Physiologic Venous Dilation, Air Travel
- Being tested
- Enoxaparine, Knee-High Graduated Compression Stockings, Standardized Bilateral Popliteal Vein Ultrasound
- Keywords
- Compression Stockings, Air Travel, Popliteal Vein, Duplex Ultrasound, Medical Tourism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparineDrug
All patients got enoxaparin to prevent blood clots
Knee-High Graduated Compression StockingsDevice
PROPOSED pressure class: 20-30 mmHg at the ankle, appropriately sized according to calf and ankle circumference, worn from approximately 1 hour before boarding until completion of the arrival ultrasound. The final product, pressure class, fitting method, and wear instructions must be confirmed. Linked arm/group(s): Moderate Compression Stockings.
Standardized Bilateral Popliteal Vein UltrasoundDiagnostic test
Triplicate bilateral diameter and cross-sectional-area measurements after a standardized rest period, with compressibility and flow assessment by an assessor masked to allocation. Linked arm/group(s): Moderate Compression Stockings, No Compression Stockings.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Compression Stockings | Experimental | Participants wear properly fitted knee-high graduated compression stockings during the qualifying flight, beginning approximately 1 hour before boarding and removing them after the arrival ultrasound. all patients got enoxaparin to prevent blood clots Receives: Drug: Enoxaparine; Device: Knee-High Graduated Compression Stockings; Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound |
| No Compression Stockings | Active comparator | Participants do not wear compression stockings or another lower-limb compression device during the qualifying flight. All patients got enoxaparin to prevent blood clots Receives: Drug: Enoxaparine; Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Change in Mean Bilateral Popliteal Vein Diameter
Between-group difference in baseline-to-arrival change in the mean of triplicate anteroposterior diameter measurements from both legs, reported in millimeters and percent change.
Measured: Within 24 hours before departure and within 2 hours after arrival at the study site. 2 days
Secondary outcomes (2)
Incidence of Stocking-Related Adverse Effects
Proportion with skin injury, numbness, clinically significant pain, intolerance, or early removal attributed to the stocking.
Measured: From stocking application through 24 hours after arrival. 5 days
Incidental Venous Thrombosis or Abnormal Compressibility
Number and proportion with an ultrasound abnormality requiring urgent clinical assessment.
Measured: From preflight baseline through 48 hours after arrival - 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Jan 2024
- Primary completion1 Sep 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physiologic Venous DilationStudies of the same condition, open and under way.
- More trials run by Research IncThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugo Aguilar, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810192
- Sponsor's protocol ID
- 017
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoyos AE, Ramirez B, Benavides J, Perez Pachon ME, Varela A. Aeromedical Considerations for Patient Safety in Aesthetic Medical Tourism. Aerosp Med Hum Perform. 2024 Oct;95(10):765-770. doi: 10.3357/AMHP.6432.2024.
PubMed 39431700
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Assessor-Masked Trial of Moderate Graduated Compression Stockings for Popliteal Vein Dilation During Long-Haul Economy-Class Air Travel After Aesthetic Surgery
- ClinicalTrials.gov ID
- NCT07810192
- Acronym / sponsor ID
- 017
- Conditions
- Physiologic Venous Dilation, Air Travel
- Keywords
- Compression Stockings, Air Travel, Popliteal Vein, Duplex Ultrasound, Medical Tourism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Research IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Sep 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 randomized assessor-masked trial will evaluate whether knee-high moderate graduated compression stockings reduce popliteal vein dilation during long-haul economy-class air travel to Bogota. Participants will be assigned to stockings or no stockings and will undergo bilateral ultrasound before flight, within 2 hours after arrival, and at 24 and 48 hours. The primary outcome is the between-group difference in change in mean bilateral popliteal vein diameter from preflight baseline to arrival.
Detailed description
Eligible economy-class travelers will be randomized before departure. The intervention group will wear properly fitted knee-high graduated compression stockings from approximately 1 hour before boarding through the arrival ultrasound; the control group will not use lower-limb compression. A masked ultrasound assessor will obtain standardized bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours. Adherence, movement, hydration, symptoms, and skin effects will be recorded. Intention-to-treat mixed models will estimate immediate and persistent treatment effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Compression Stockings | Experimental | Drug: Enoxaparine, Device: Knee-High Graduated Compression Stockings, Diagnostic Test: Standardized Bilateral Popliteal Vein UltrasoundParticipants wear properly fitted knee-high graduated compression stockings during the qualifying flight, beginning approximately 1 hour before boarding and removing them after the arrival ultrasound. all patients got enoxaparin to prevent blood clots |
| No Compression Stockings | Active comparator | Drug: Enoxaparine, Diagnostic Test: Standardized Bilateral Popliteal Vein UltrasoundParticipants do not wear compression stockings or another lower-limb compression device during the qualifying flight. All patients got enoxaparin to prevent blood clots |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 65 years.
- Economy-class commercial itinerary to Bogota with at least 4 hours of total airborne time.
- No clinical indication that mandates or prohibits compression stockings.
- Ability to obtain the assigned stocking before boarding and wear it as instructed.
- Standardized preflight and postarrival ultrasounds completed before surgery.
Key exclusion criteria (6 listed)
- Current deep venous thrombosis, therapeutic anticoagulation, or severe peripheral arterial disease.
- Significant lower-limb skin disease, ulceration, neuropathy, or deformity preventing safe stocking use.
- Pregnancy.
- Planned use of another compression device during the flight.
- Surgery or major intravenous fluid therapy before completion of the 48-hour examination.
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 |
|---|---|---|
| EnoxaparineAll patients got enoxaparin to prevent blood clots | Drug | Moderate Compression Stockings, No Compression Stockings |
| Knee-High Graduated Compression StockingsPROPOSED pressure class: 20-30 mmHg at the ankle, appropriately sized according to calf and ankle circumference, worn from approximately 1 hour before boarding until completion of the arrival ultrasound. The final product, pressure class, fitting method, and wear instructions must be confirmed. Linked arm/group(s): Moderate Compression Stockings. | Device | Moderate Compression Stockings |
| Standardized Bilateral Popliteal Vein UltrasoundTriplicate bilateral diameter and cross-sectional-area measurements after a standardized rest period, with compressibility and flow assessment by an assessor masked to allocation. Linked arm/group(s): Moderate Compression Stockings, No Compression Stockings. | Diagnostic test | Moderate Compression Stockings, No Compression Stockings |
Primary outcome
Difference in Change in Mean Bilateral Popliteal Vein Diameter
Time frame: Within 24 hours before departure and within 2 hours after arrival at the study site. 2 days
Between-group difference in baseline-to-arrival change in the mean of triplicate anteroposterior diameter measurements from both legs, reported in millimeters and percent change.
2 secondary outcomes
Incidence of Stocking-Related Adverse Effects
Time frame: From stocking application through 24 hours after arrival. 5 days
Incidental Venous Thrombosis or Abnormal Compressibility
Time frame: From preflight baseline through 48 hours after arrival - 1 week
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 9 Sep 2026.
- Background: PubMed 39431700Hoyos AE, Ramirez B, Benavides J, Perez Pachon ME, Varela A. Aeromedical Considerations for Patient Safety in Aesthetic Medical Tourism. Aerosp Med Hum Perform. 2024 Oct;95(10):765-770. doi: 10.3357/AMHP.6432.2024.
Related trials for Physiologic Venous Dilation
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Prospective Stratified Randomized Four-Group Study of Cabin Class and Graduated Compression Stockings on Popliteal Vein Dilation After Long-Haul Air Travel After Aesthetic Surgery
Physiologic Venous Dilation, Air Travel
RecruitingObservational study
Prospective Comparative Cohort Study of Premium Versus Economy Cabin Travel and Popliteal Vein Diameter After Long-Haul Flight After an Aesthetic Surgery
Physiologic Venous Dilation, Air Travel
RecruitingObservational study
Prospective Repeated-Measures Study of Popliteal Vein Diameter During the First 48 Hours After Commercial Air Travel to Bogota for a Plastic Surgery Intervention
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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.
Hugo Aguilar principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enoxaparine, Knee-High Graduated Compression Stockings and Standardized Bilateral Popliteal Vein Ultrasound in people with Physiologic Venous Dilation and Air Travel, run by Research Inc at 1 site in Colombia.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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 Colombia. 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?
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 Hugo Aguilar, MD, Plastic surgeon (+57 301 6918526, havplasticacademy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Change in Mean Bilateral Popliteal Vein Diameter (time frame: Within 24 hours before departure and within 2 hours after arrival at the study site. 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07810192, which also lists 1 linked publication.
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 9 Sep 2026.