An interventional study of Enoxaparine and Knee-High Graduated Compression Stockings in Physiologic Venous Dilation and Air Travel, sponsored by Research Inc. Recruiting at 1 site in Colombia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Research Inc · Not applicable, Interventional, and Prevention
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.
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.
Research Inc is the lead sponsor of 24 studies on the registry; 22 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Enoxaparine · Device: Knee-High Graduated Compression Stockings · Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound
Participants do not wear compression stockings or another lower-limb compression device during the qualifying flight. All patients got enoxaparin to prevent blood clots
Drug: Enoxaparine · Diagnostic Test: Standardized Bilateral Popliteal Vein Ultrasound
All patients got enoxaparin to prevent blood clots
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.
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.
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.
Time frame: Within 24 hours before departure and within 2 hours after arrival at the study site. 2 days
Incidence of Stocking-Related Adverse Effects
Proportion with skin injury, numbness, clinically significant pain, intolerance, or early removal attributed to the stocking.
Time frame: 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.
Time frame: From preflight baseline through 48 hours after arrival - 1 week
Ran from Jan 2024 to primary completion in Sep 2026, 32 months.
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