Deep Vein ThrombosisNCT03368313
Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis
A study testing Circaid in people with Deep Vein Thrombosis and Post Thrombotic Syndrome, run by Pró Circulação® at 18 sites in Brazil.
Trial summary
The objective of the study is to conduct a Bayesian randomized trial comparing non-elastic compression garments applied with high pressure (Circaid group) with no compression (control group) in reducing signs and symptoms in the acute stage of DVT and subsequent postthrombotic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Deep Vein Thrombosis, Post Thrombotic Syndrome
- What is being tested?
- Circaid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 18 sitesBrazil
- Study dates
- 1 May 2018to 30 Nov 2025
- 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
- Age 18-80 years
- Outpatients with acute deep venous thrombosis of lower extremity
- Symptomatic patients
- Involving femoro-popliteal and / or ilofemoral segment
- Symptoms less than two weeks
- Provoked or unprovoked TVP
Who cannot join
- History of TVP
- Any allergy to the use of compression material
- Severe arterial occlusive disease
- Patients in whom thrombus removal is planned
- Ankle index <0.5
- Inability to walk
Show all 9Show fewer
- A life expectancy of less than six months
- Geographic inaccessibility that prevents adequate follow-up with or without assistance
- Thrombolytic therapy outside of this study for the initial treatment of acute DVT.
Trial locations and contacts
18 sites in 1 country.
Clodoaldo A De Sá, Ph.D. contact
18 sites in 1 country
Brazil18 sites, 18 recruiting
- Recruiting
Instituto de Cirurgia Vascular e Angiologia de Cascavel/PR
Cascavel, Paraná
Jeferson Toregeani
- Recruiting
Clínica Médica Longevittá
Cuiabá, Mount
Alex Dornelles
- Recruiting
Hospital Erasto Gaertner
Curitiba, Paraná
Fabiano Luiz Erzinger
- Recruiting
Hospital Santa Casa de Curitiba
Curitiba, Paraná
Francisco Eduardo Coral
- Recruiting
NICEP - Núcleo Integrado de Cirurgia Vascular e Pesquisa
Curitiba, Paraná
Rosangela da Silva
- Recruiting
Sociedade Evangélica Beneficente de Curitiba
Curitiba, Paraná
Antonio Lacerda
- Recruiting
Angiodiagnóstico - Instituto de Doenças Venosas e Linfáticas de Goiânia/Go
Goiânia, Goiás
Fabricio Santiago
- Recruiting
Flebocurso
Londrina, Paraná
Felipe Coelho
- Recruiting
Angio Vascular Hospital LTDA
Natal, Rio Grande do Norte
Gutenberg do Amaral Gurgel
- Recruiting
Centro: Serviço de Cirurgia Vascular HSLPUCRS
Porto Alegre, Rio Grande do Sul
Luciane Barreneche
- Recruiting
Clínica vascular MDC Sociedade Simples ME
Porto Alegre, Rio Grande do Sul
Luciano Amaral Domingues
- Recruiting
Hospital dos Servidores do Estado do Pernambuco
Recife, Pernambuco
Carlos Eduardo Cunha
- Recruiting
Instituto de Ensino e Treinamento em Saúde Vascular da Bahia
Salvador, Estado de Bahia
Ronald Fidelis
- Recruiting
Clínica Dr. Alexandre Reis EIRELI
Santos, São Paulo
Alexandre Reis e Silva
- Recruiting
CIP - Fundação Faculdade de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo
Tiago Maschio
- Recruiting
SAMAR Serviços Médicos
São Paulo, São Paulo
Marita Von Rautenfeld
- Recruiting
Pró Saúde Clínica Médica
Tubarão, Santa Catarina
Renan Candemil
- Recruiting
Pró Circulação® - Clinic of Angiology and Vascular Surgery
Xanxerê, Santa Catarina
Eduardo Matta
About this study
Official title: Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis: A Bayesian Adaptive Randomized Trial
The objective of the study is to conduct a Bayesian randomized trial comparing non-elastic compression garments applied with high pressure (Circaid group) with no compression (control group) in reducing signs and symptoms in the acute stage of DVT and subsequent postthrombotic syndrome. With a hypothesis that the Circaid group will present a quicker and more marked reduction of pain and leg swelling in the acute stage of DVT, as well as a 20% decrease in the frequency of postthrombotic syndrome within six months from the time of diagnosis of the acute deep vein thrombosis episode.
Read the detailed description
The pain-relief and edema reduction associated with compressive therapy in patients with acute deep vein thrombosis (DVT) have been poorly documented in randomized controlled trials (RCTs). Compressive therapy is controversial in that it is currently unclear whether or not it might reduce the risk of postthrombotic syndrome (PTS), a chronic disorder identified in 25-50% of patients with a previous diagnosis of deep venous thrombosis. With the recent SOX trial deeming elastic compression stockings to be ineffective in preventing postthrombotic syndrome and with criticisms focused on the difficulty concerning patients' compliance with these devices, alternative methods such as non-elastic compression garments have been considered. Unfortunately, to our knowledge, no trials have investigated these devices applied with a greater pressure than compression stockings in the context of preventing pain and swelling in the acute DVT phase and of late complications (postthrombotic syndrome).
The experimental literature evaluating non-elastic compression garments is primarily focused on venous insufficiency rather than deep vein thrombosis. For example, previous randomized trial patients allocated to non-elastic compression garments presented faster healing rates/week for venous leg ulcers than a group receiving four-layered compression garments. Although this evidence is related to venous insufficiency, there are currently no RCTs exploring the effect of non-elastic compression in preventing postthrombotic syndrome.
Given this gap in the literature, study aimed at conducting a Bayesian randomized trial to assess a non-elastic compression garment (Circaid) versus a control group in patients with acute DVT.
- Conditions
- Deep Vein Thrombosis, Post Thrombotic Syndrome
- Being tested
- Circaid
- Keywords
- Nonelastic compression theraphy, Compression theraphy, Compression stockings
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircaidDevice
Circaid is a velcro compression device for the calf (Circaid Juxtalite® Lower Leg; Medi Gmbh, Bayreuth, Germany), thigh and knee (Circaid Juxtafit; Medi Gmbh, Bayreuth, Germany). The Circaid device will be applied with an average pressure of more than 40 mmHg, verified through a BPS (built-in pressure system).
| Study group | Role | What they receive |
|---|---|---|
| Compression arm | Experimental | The compression arm will receive an adjustable velcro compression device for the calf (Circaid Juxtalite® Lower Leg; Medi Gmbh, Bayreuth, Germany), thigh and knee (Circaid Juxtafit; Medi Gmbh, Bayreuth, Germany). The Circaid device will be applied with an average pressure of more than 40 mmHg, verified through a BPS (built-in pressure system). Receives: Device: Circaid |
| Control arm | No intervention | No compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain level using visual analog scale
Pain level will be registered using a pain visual analog scale (VAS). The pain VAS ranges from 0 (no pain at all) to 10 (very severe pain) and is a self-reported scale where the patient is asked to mark his/her pain level on the line between the two endpoints. A higher score indicates a greater pain intensity.
Measured: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
Change in edema using perimetry (cm)
The circumference will be measured at two different levels of the foot and at five distinct levels of the leg, using a normal tape measure. No pressure will be applied to these measures to avoid affecting their accuracy. The measurement of the first foot is made five centimeters proximal to the base of the first proximal phalanx of the second toe and the second measurement five centimeters proximal to the first measurement. The measurement of the first leg will be performed five centimeters above the lower edge of the lateral malleolus and then every five centimeters, reaching a total of six to eight measurements, depending on the height of the leg.
Measured: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
Secondary outcomes (5)
Postthrombotic syndrome (PTS) using Ginsberg's criteria
PTS will be diagnosed following Ginsberg's criteria of ipsilateral pain and swelling of legs at least one month's duration presenting the following characteristics: Worse at the end of the day or with prolonged sitting or standing, and better after a night's rest and with leg elevation.
Measured: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
Postthrombotic syndrome (PTS) using Villalta's scale
The cumulative incidence and severity of post-thrombotic syndrome (PTS) will be recorded with Villalta's scale. The scale consists of five patient-rated venous symptoms (pain, cramps, heaviness, paresthesia, and pruritis) and six clinician-rated physical signs (pretibial edema, skin induration, hyperpigmentation, pain during calf compression, venous ectasia, and redness) which are each rated on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe). Points are summed to produce the total score ranging from 0-33. Patients are classified as having PTS if the score is >=5 or if a venous ulcer is present. A score of 5-9 signifies mild disease, 10-14 moderate disease, and ≥15 severe disease.
Measured: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
Quality of life using VEINES-QOL/Sym questionnaire
VEnous INsufficiency Epidemiological and Economic Study- Quality of Life/ Symptoms (VEINES-QOL/Sym) is a 26-item patient-reported questionnaire measuring the impact of deep venous thrombosis on symptoms and quality of life. Out of two summary scores, the VEINES-QOL summary score (25 items) provides an estimate of the overall impact of deep venous thrombosis on the patient's quality of life and the VEINES-Sym summary score (10 items) measures symptom severity. This includes nine venous symptoms (heavy legs, aching legs, swelling, night cramps, heat or burning sensation, restless legs, throbbing, itching, tingling sensation), rated on a five-point Likert scale of frequency (every day, several times a week, about once a week, less than once a week, never), and leg pain rated on a six-point scale of intensity (very severe, severe, moderate, mild, very mild, none). For both scales, high scores indicate better outcomes.
Measured: Baseline visit and at one, six and 12 months of followup visits.
Quality of life using PROMIS Global-10
PROMIS-10 assesses general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life.
Measured: Baseline visit and at one, six and 12 months of followup visits.
Physical activity using Global Physical Activity Questionnaire
Global Physical Activity Questionnaire (GPAQ) developed by WHO collects information on physical activity participation in three settings (or domains) as well as sedentary behavior, comprising 16 questions (P1-P16). The domains are: Activity at work; Travel to and from places; Recreational activities. Metabolic Equivalents (MET) are commonly used to express the intensity of physical activities, and are also used for the analysis of GPAQ data. MET is the ratio of a person's working metabolic rate relative to the resting metabolic rate. One MET is defined as the energy cost of sitting quietly, and is equivalent to a caloric consumption of 1 kcal/kg/hour. When calculating a person's overall energy expenditure using GPAQ data, 4 METs get assigned to the time spent in moderate activities, and 8 METs to the time spent in vigorous activities.
Measured: Baseline visit and at one, six and 12 months of followup visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 May 2018
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pró Circulação®
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Matta, MD, Principal investigator, Pró Circulação®
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368313
- Sponsor's protocol ID
- Circaid
- Status last verified
- Sep 2021
- First submitted
- 28 Nov 2017
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis: A Bayesian Adaptive Randomized Trial
- ClinicalTrials.gov ID
- NCT03368313
- Acronym / sponsor ID
- Circaid
- Conditions
- Deep Vein Thrombosis, Post Thrombotic Syndrome
- Keywords
- Nonelastic compression theraphy, Compression theraphy, Compression stockings
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pró Circulação®University, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 11 Dec 2017 (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.
The objective of the study is to conduct a Bayesian randomized trial comparing non-elastic compression garments applied with high pressure (Circaid group) with no compression (control group) in reducing signs and symptoms in the acute stage of DVT and subsequent postthrombotic syndrome. With a hypothesis that the Circaid group will present a quicker and more marked reduction of pain and leg swelling in the acute stage of DVT, as well as a 20% decrease in the frequency of postthrombotic syndrome within six months from the time of diagnosis of the acute deep vein thrombosis episode.
Detailed description
The pain-relief and edema reduction associated with compressive therapy in patients with acute deep vein thrombosis (DVT) have been poorly documented in randomized controlled trials (RCTs). Compressive therapy is controversial in that it is currently unclear whether or not it might reduce the risk of postthrombotic syndrome (PTS), a chronic disorder identified in 25-50% of patients with a previous diagnosis of deep venous thrombosis. With the recent SOX trial deeming elastic compression stockings to be ineffective in preventing postthrombotic syndrome and with criticisms focused on the difficulty concerning patients' compliance with these devices, alternative methods such as non-elastic compression garments have been considered. Unfortunately, to our knowledge, no trials have investigated these devices applied with a greater pressure than compression stockings in the context of preventing pain and swelling in the acute DVT phase and of late complications (postthrombotic syndrome).
The experimental literature evaluating non-elastic compression garments is primarily focused on venous insufficiency rather than deep vein thrombosis. For example, previous randomized trial patients allocated to non-elastic compression garments presented faster healing rates/week for venous leg ulcers than a group receiving four-layered compression garments. Although this evidence is related to venous insufficiency, there are currently no RCTs exploring the effect of non-elastic compression in preventing postthrombotic syndrome.
Given this gap in the literature, study aimed at conducting a Bayesian randomized trial to assess a non-elastic compression garment (Circaid) versus a control group in patients with acute DVT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression arm | Experimental | Device: CircaidThe compression arm will receive an adjustable velcro compression device for the calf (Circaid Juxtalite® Lower Leg; Medi Gmbh, Bayreuth, Germany), thigh and knee (Circaid Juxtafit; Medi Gmbh, Bayreuth, Germany). The Circaid device will be applied with an average pressure of more than 40 mmHg, verified through a BPS (built-in pressure system). |
| Control arm | No intervention | –No compression |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years
- Outpatients with acute deep venous thrombosis of lower extremity
- Symptomatic patients
- Involving femoro-popliteal and / or ilofemoral segment
- Symptoms less than two weeks
Key exclusion criteria (9 listed)
- History of TVP
- Any allergy to the use of compression material
- Severe arterial occlusive disease
- Patients in whom thrombus removal is planned
- Ankle index <0.5
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 |
|---|---|---|
| CircaidCircaid is a velcro compression device for the calf (Circaid Juxtalite® Lower Leg; Medi Gmbh, Bayreuth, Germany), thigh and knee (Circaid Juxtafit; Medi Gmbh, Bayreuth, Germany). The Circaid device will be applied with an average pressure of more than 40 mmHg, verified through a BPS (built-in pressure system). | Device | Compression arm |
Primary outcome
Change in pain level using visual analog scale
Time frame: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
Pain level will be registered using a pain visual analog scale (VAS). The pain VAS ranges from 0 (no pain at all) to 10 (very severe pain) and is a self-reported scale where the patient is asked to mark his/her pain level on the line between the two endpoints. A higher score indicates a greater pain intensity.
Change in edema using perimetry (cm)
Time frame: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
The circumference will be measured at two different levels of the foot and at five distinct levels of the leg, using a normal tape measure. No pressure will be applied to these measures to avoid affecting their accuracy. The measurement of the first foot is made five centimeters proximal to the base of the first proximal phalanx of the second toe and the second measurement five centimeters proximal to the first measurement. The measurement of the first leg will be performed five centimeters above the lower edge of the lateral malleolus and then every five centimeters, reaching a total of six to eight measurements, depending on the height of the leg.
5 secondary outcomes
Postthrombotic syndrome (PTS) using Ginsberg's criteria
Time frame: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
Postthrombotic syndrome (PTS) using Villalta's scale
Time frame: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
Quality of life using VEINES-QOL/Sym questionnaire
Time frame: Baseline visit and at one, six and 12 months of followup visits.
Quality of life using PROMIS Global-10
Time frame: Baseline visit and at one, six and 12 months of followup visits.
Physical activity using Global Physical Activity Questionnaire
Time frame: Baseline visit and at one, six and 12 months of followup visits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Circaid, a non-elastic compression garmentLink provided by the sponsor.
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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.
Clodoaldo A De Sá, Ph.D. contact
Eduardo Matta, MD principal investigator
Pró Circulação®
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circaid in people with Deep Vein Thrombosis and Post Thrombotic Syndrome, run by Pró Circulação® at 18 sites in Brazil.
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 9 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: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Matta, MD (55 (49) 3433-9050, procirculacao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain level using visual analog scale (time frame: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.). The study lists 2 primary outcomes in all. 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 28 Sep 2022.