Risk of Venous ThrombosisNCT02803398
Modelling Interface Pressure Applied by Superimposed Compression Bandages
A study testing Compression bandages application and interface pressure measurements in people with Risk of Venous Thrombosis, run by Thuasne at 1 site in France.
Trial summary
The aim of the study is to measure and model interface pressure applied on the lower leg of patients at risk of veinous thrombosis, by different bandage combinations, composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann \& Rauscher). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Risk of Venous Thrombosis
- What is being tested?
- Compression bandages application and interface pressure measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Dec 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 80 years old
- at risk of venous thrombosis, who need to wear compression (socks, stockings or bandage)
- Hospitalized in the Service of Physical Medicine and Rehabilitation, in Saint-Etienne, France
- BMI between 20 and 35
- Able to stand for at least 10 minutes in a standing frame
- Signed informed consent to take part in the study
- Covered by a health insurance system
- Not taking part in another study which interfere with the results of the present study
Who cannot join
- Compression bandages contraindications
- Allergy to one of the different bandages components
- History of deep or superficial vein thrombosis
- Venous or arterial ulcer
- Cutaneous wound on the lower leg
- Cognitive, behavior or physical disorder preventing the communication and the active participation to a rehabilitation program, or a clinical study
- Patient under any legal protection (except curatorship)
- Not covered by a health insurance system
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Physique et de Réadaptation, CHU Bellevue
Saint-Etienne, 42000
About this study
The aim of the study is to measure and model interface pressure applied on the lower leg of patients at risk of veinous thrombosis, by different bandage combinations, composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann \& Rauscher). The patient specific model should better predict the interface pressure distribution than Laplace's Law.
Read the detailed description
The measurement of the patients' legs shapes will be performed thanks to an optical scanner. The patients' posterior part of the calf will be submitted to a localized compression test, in order to characterize the soft tissue mechanical properties of both legs.
Pressure measurements, applied by the different bandages, will be taken at the height of measurement points B1 and C on the lateral and medial sides of the leg in supine, sitting and standing positions, on both legs.
2 single bandages (Biflex 16 (Thuasne) and Rosidal K (Lohmann \& Rauscher)) and their different combinations will be applied on the patient's legs.
The order of bandage application for each patient is randomized, but is the same for both legs. The order of the leg (right or left) on which the bandages are applied is randomized.
- Conditions
- Risk of Venous Thrombosis
- Being tested
- Compression bandages application and interface pressure measurements
- Keywords
- Compression bandages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression bandages application and interface pressure measurementsOther
Bandages, which are applied in a spiral pattern on the leg, are composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann \& Rauscher).
| Study group | Role | What they receive |
|---|---|---|
| Patient at risk of venous thrombosis | Experimental | Not described Receives: Other: Compression bandages application and interface pressure measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency between interface pressure [mmHg] given by the patient-specific simulation and the experimental pressure measurements for different positions (supine, sitting, standing) and the different bandage combinations.
Measured: Through study completion (one year)
Secondary outcomes (1)
Evaluation of the impact of soft tissue mechanical propreties on interface pressure
Patient's leg soft tissue mechanical properties are characterized for both patient's legs before bandage application. The impact of this parameter on the measured interface pressure will be evaluated.
Measured: Through study completion (one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
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 Risk of Venous ThrombosisStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal Giraux, MD, PhD, Principal investigator, Service de Médecine Physique et de Réadaptation, CHU Saint-Etienne, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803398
- Sponsor's protocol ID
- 2015-A01219-40
- Status last verified
- Dec 2016
- First submitted
- 8 Jun 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Chassagne F, Helouin-Desenne C, Molimard J, Convert R, Badel P, Giraux P. Superimposition of elastic and nonelastic compression bandages. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):851-858. doi: 10.1016/j.jvsv.2017.07.006.
PubMed 29037358
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modelling Interface Pressure Applied by Superimposed Compression Bandages
- ClinicalTrials.gov ID
- NCT02803398
- Acronym / sponsor ID
- 2015-A01219-40
- Conditions
- Risk of Venous Thrombosis
- Keywords
- Compression bandages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- First posted
- 17 Jun 2016 (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.
The aim of the study is to measure and model interface pressure applied on the lower leg of patients at risk of veinous thrombosis, by different bandage combinations, composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann \& Rauscher). The patient specific model should better predict the interface pressure distribution than Laplace's Law.
Detailed description
The measurement of the patients' legs shapes will be performed thanks to an optical scanner. The patients' posterior part of the calf will be submitted to a localized compression test, in order to characterize the soft tissue mechanical properties of both legs.
Pressure measurements, applied by the different bandages, will be taken at the height of measurement points B1 and C on the lateral and medial sides of the leg in supine, sitting and standing positions, on both legs.
2 single bandages (Biflex 16 (Thuasne) and Rosidal K (Lohmann \& Rauscher)) and their different combinations will be applied on the patient's legs.
The order of bandage application for each patient is randomized, but is the same for both legs. The order of the leg (right or left) on which the bandages are applied is randomized.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient at risk of venous thrombosis | Experimental | Other: Compression bandages application and interface pressure measurements |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female between 18 and 80 years old
- at risk of venous thrombosis, who need to wear compression (socks, stockings or bandage)
- Hospitalized in the Service of Physical Medicine and Rehabilitation, in Saint-Etienne, France
- BMI between 20 and 35
- Able to stand for at least 10 minutes in a standing frame
Key exclusion criteria (8 listed)
- Compression bandages contraindications
- Allergy to one of the different bandages components
- History of deep or superficial vein thrombosis
- Venous or arterial ulcer
- Cutaneous wound on the lower leg
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 bandages application and interface pressure measurementsBandages, which are applied in a spiral pattern on the leg, are composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann \& Rauscher). | Other | Patient at risk of venous thrombosis |
Primary outcome
Consistency between interface pressure [mmHg] given by the patient-specific simulation and the experimental pressure measurements for different positions (supine, sitting, standing) and the different bandage combinations.
Time frame: Through study completion (one year)
1 secondary outcome
Evaluation of the impact of soft tissue mechanical propreties on interface pressure
Time frame: Through study completion (one year)
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 29 Dec 2016.
- Derived from this study: PubMed 29037358Chassagne F, Helouin-Desenne C, Molimard J, Convert R, Badel P, Giraux P. Superimposition of elastic and nonelastic compression bandages. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):851-858. doi: 10.1016/j.jvsv.2017.07.006.
- Individual participant dataSharing planned: Undecided
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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.
Pascal Giraux, MD, PhD principal investigator
Service de Médecine Physique et de Réadaptation, CHU Saint-Etienne, France
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 bandages application and interface pressure measurements in people with Risk of Venous Thrombosis, run by Thuasne at 1 site in France.
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 8 inclusion and 8 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 29 Dec 2016. 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 France. 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?
Consistency between interface pressure [mmHg] given by the patient-specific simulation and the experimental pressure measurements for different positions (supine, sitting, standing) and the different bandage combinations. (time frame: Through study completion (one year)). 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 NCT02803398, 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 29 Dec 2016.