An interventional study of Circaid in Deep Vein Thrombosis and Post Thrombotic Syndrome, sponsored by Pró Circulação®. Recruiting at 18 sites in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Pró Circulação® · Not applicable, Interventional, and Treatment
Among 31 studies in Venous Thrombosis with a site in Brazil — 4 open to participants now, 4 under way, none of them phase 3. Venous Thrombosis · Brazil.
Among the 31 studies in Venous Thrombosis with a site in Brazil, this one is the 21st largest by planned enrollment of the 27 interventional ones that give a count, is one of 2 that started in 2018, is one of 7 with no phase, and was the 26th registered.
785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.
Browse Venous Thrombosis studies →4 of the 31 studies in Venous Thrombosis with a site in Brazil are open now. Recruiting first, the newest first:
Hospital de Clinicas de Porto Alegre · Sites in Brazil
Science Valley Research Institute · Sites in Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto · Sites in Brazil
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 84 Venous Thrombosis studies recruiting now, 59 (70%) set no upper age limit and 9 (11%) stop at 75 or younger; 10 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2018.
This study's planned enrollment of 120 is below the median of 152 across 477 interventional studies indexed under Venous Thrombosis.
Median enrollment 1,215 across the 27 interventional studies, 145 across the 4 observational. Of the 23 that completed or were terminated, 12 (52%) have results posted.
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16 of 31 have an industry lead sponsor. The 10 most frequent:
Pró Circulação® is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Pró Circulação® has 1 study filed under Venous Thrombosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 31 studies in Venous Thrombosis with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: Circaid
No compression
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).
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.
Time frame: 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.
Time frame: Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline visit and at one, six and 12 months of followup visits.
Started May 2018 (actual). Primary completion is estimated for Nov 2023, 66 months after the start.
Of 99 non-industry interventional studies with no phase under Venous Thrombosis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's planned 66 months is above that.
Counting every sponsor, half of 117 studies reached it within 34 months; a quarter within 13 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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