Edema LegNCT03546725
The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights
A study testing Compression stocking in people with Edema Leg, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
Compression stockings have beneficial effects on the development of venous thromboembolic complications and oedema during long- haul flights. A randomized controlled trial investigating the effect of compression stockings during short-haul flights with a duration less than fur ours is lacking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edema Leg
- What is being tested?
- Compression stocking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Feb 2018to 26 May 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult participants ≥ 18 years of both sexes. Otherwise no restriction, since each participant acts as their own control.
Who cannot join
- Any condition requiring compression stockings during short-haul flights. Severe arterial insufficiency in the lower extremities.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
Copenhagen, 2730
About this study
Official title: The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights: A Randomized Controlled Trial
Compression stockings have beneficial effects on the development of venous thromboembolic complications and oedema during long- haul flights. A randomized controlled trial investigating the effect of compression stockings during short-haul flights with a duration less than fur ours is lacking. Deep vein thrombosis is very rare on flights shorter than four hours, but compression stocking could have beneficial effects on other outcomes. The aim of this study is to assess if compression stockings used during a 3-3.5-hour flight will decrease leg edema and discomfort.
Read the detailed description
All participants will be adults who will undergo a 3-3.5 hours flight. Participants have received oral and written information about the trial. All compression stockings have a class two compression level (corresponding to 23-32 mmHg compression). Participants will be randomized to wear a compression stocking on one leg, while the other side acts as control. Within an hour preflight, the patient will measure ankle and calf circumference at marked circumferential areas on the leg and answer questionnaires regarding leg pain and subjective discomfort, whereafter the stocking will be put on, on the randomized side. Within one hour after the flight the stocking will be removed and patients will once again measure the ankle and calf circumference at the marked circumference and fill out the questionnaire.
Sample size: Mean difference in ankle circumference set to -0.19 cm. Standard deviation of the mean difference set to 0.3, 5% alfa and 80% power. Sample size with a paired design = at least 18 participants. However, for practical reasons we will include up to approximately 50 adults in the trial.
Withdrawal and dropout criteria: All participants can withdraw their consent at any point during the trial, without the need for explaining any reasons for withdrawal. Since compression stockings do not cause side effects, except for patients with severe arterial insufficiency in the legs, we do not expect the trial to be stopped due to complications. All withdrawals will be accounted for in the scientific publication.
- Conditions
- Edema Leg
- Being tested
- Compression stocking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression stockingDevice
Compression stocking with length below the knee and a class two compression level (corresponding to 23-32 mmHg compression).
| Study group | Role | What they receive |
|---|---|---|
| Leg with compression stocking | Experimental | Leg wearing compression stocking during the flight Receives: Device: Compression stocking |
| Leg without compression stocking | No intervention | Leg not wearing compression stocking during the flight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle edema
Difference in ankle circumference pre- and post flight on the leg with and the leg without compression stocking.
Measured: Ankle circumference on the leg wearing a compression stocking and the leg not wearing compression stocking is measured up to one hour before, and one hour after flight.
Secondary outcomes (3)
Calf edema
Difference in calf circumference pre- and post flight on the leg with and the leg without compression stocking.
Measured: Calf circumference on the leg wearing a compression stocking and the leg not wearing compression stocking is measured up to one hour before, and one hour after flight.
Leg pain
Self-reported assessment of leg pain on a Visual Analogue Scale.
Measured: Leg pain is reported up to one hour before, and one hour after flight.
Leg discomfort
Self-reported assessment of leg discomfort on a Visual Analogue Scale.
Measured: Leg discomfort is reported up to one hour before, and one hour after flight.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start8 Feb 2018
- Primary completion26 May 2018
- Study completion26 May 2018
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 Edema LegStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomised to wear a compression stocking on either the left or the right leg during a 3 - 3.5 hour flight. All participants will act as their own control, and as a result all data will be paired.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Hjalde Halmsted Olsen, Herlev and Gentofte Hospital
- Investigators
- Joachim HH Olsen, BScMed, Principal investigator, Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of CopenhagenStina Öberg, MD, Study director, Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of CopenhagenJacob Rosenberg, MD, DMSc, Study director, Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546725
- Sponsor's protocol ID
- 8392100
- Status last verified
- Jun 2018
- First submitted
- 23 May 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olsen JHH, Oberg S, Rosenberg J. The effect of compression stocking on leg edema and discomfort during a 3-hour flight: A randomized controlled trial. Eur J Intern Med. 2019 Apr;62:54-57. doi: 10.1016/j.ejim.2019.01.013. Epub 2019 Feb 7.
PubMed 30738701
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03546725
- Acronym / sponsor ID
- 8392100
- Conditions
- Edema Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 26 May 2018 (actual)
- Study completion
- 26 May 2018 (actual)
- First posted
- 6 Jun 2018 (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.
Compression stockings have beneficial effects on the development of venous thromboembolic complications and oedema during long- haul flights. A randomized controlled trial investigating the effect of compression stockings during short-haul flights with a duration less than fur ours is lacking. Deep vein thrombosis is very rare on flights shorter than four hours, but compression stocking could have beneficial effects on other outcomes. The aim of this study is to assess if compression stockings used during a 3-3.5-hour flight will decrease leg edema and discomfort.
Detailed description
All participants will be adults who will undergo a 3-3.5 hours flight. Participants have received oral and written information about the trial. All compression stockings have a class two compression level (corresponding to 23-32 mmHg compression). Participants will be randomized to wear a compression stocking on one leg, while the other side acts as control. Within an hour preflight, the patient will measure ankle and calf circumference at marked circumferential areas on the leg and answer questionnaires regarding leg pain and subjective discomfort, whereafter the stocking will be put on, on the randomized side. Within one hour after the flight the stocking will be removed and patients will once again measure the ankle and calf circumference at the marked circumference and fill out the questionnaire.
Sample size: Mean difference in ankle circumference set to -0.19 cm. Standard deviation of the mean difference set to 0.3, 5% alfa and 80% power. Sample size with a paired design = at least 18 participants. However, for practical reasons we will include up to approximately 50 adults in the trial.
Withdrawal and dropout criteria: All participants can withdraw their consent at any point during the trial, without the need for explaining any reasons for withdrawal. Since compression stockings do not cause side effects, except for patients with severe arterial insufficiency in the legs, we do not expect the trial to be stopped due to complications. All withdrawals will be accounted for in the scientific publication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomised to wear a compression stocking on either the left or the right leg during a 3 - 3.5 hour flight. All participants will act as their own control, and as a result all data will be paired.
| Arm | Type | Receives |
|---|---|---|
| Leg with compression stocking | Experimental | Device: Compression stockingLeg wearing compression stocking during the flight |
| Leg without compression stocking | No intervention | –Leg not wearing compression stocking during the flight |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult participants ≥ 18 years of both sexes. Otherwise no restriction, since each participant acts as their own control.
Key exclusion criteria (1 listed)
- Any condition requiring compression stockings during short-haul flights. Severe arterial insufficiency in the lower extremities.
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 |
|---|---|---|
| Compression stockingCompression stocking with length below the knee and a class two compression level (corresponding to 23-32 mmHg compression). | Device | Leg with compression stocking |
Primary outcome
Ankle edema
Time frame: Ankle circumference on the leg wearing a compression stocking and the leg not wearing compression stocking is measured up to one hour before, and one hour after flight.
Difference in ankle circumference pre- and post flight on the leg with and the leg without compression stocking.
3 secondary outcomes
Calf edema
Time frame: Calf circumference on the leg wearing a compression stocking and the leg not wearing compression stocking is measured up to one hour before, and one hour after flight.
Leg pain
Time frame: Leg pain is reported up to one hour before, and one hour after flight.
Leg discomfort
Time frame: Leg discomfort is reported up to one hour before, and one hour after flight.
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 13 Jun 2018.
- Derived from this study: PubMed 30738701Olsen JHH, Oberg S, Rosenberg J. The effect of compression stocking on leg edema and discomfort during a 3-hour flight: A randomized controlled trial. Eur J Intern Med. 2019 Apr;62:54-57. doi: 10.1016/j.ejim.2019.01.013. Epub 2019 Feb 7.
- 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.
Joachim HH Olsen, BScMed principal investigator
Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
Stina Öberg, MD study director
Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
Jacob Rosenberg, MD, DMSc study director
Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression stocking in people with Edema Leg, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 1 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 13 Jun 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 Denmark. 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?
Ankle edema (time frame: Ankle circumference on the leg wearing a compression stocking and the leg not wearing compression stocking is measured up to one hour before, and one hour after flight.). 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 NCT03546725, 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 13 Jun 2018.