Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis
1 other identifier
interventional
120
1 country
18
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
Longer than P75 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 11, 2017
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedSeptember 28, 2022
September 1, 2021
5.6 years
November 28, 2017
September 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
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
Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
Postthrombotic syndrome (PTS) using Villalta's scale
Baseline visit, after 15 days, one month, six months and 12 months of followup visits.
Quality of life using VEINES-QOL/Sym questionnaire
Baseline visit and at one, six and 12 months of followup visits.
Quality of life using PROMIS Global-10
Baseline visit and at one, six and 12 months of followup visits.
Physical activity using Global Physical Activity Questionnaire
Baseline visit and at one, six and 12 months of followup visits.
Study Arms (2)
Compression arm
EXPERIMENTALThe 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 INTERVENTIONNo compression
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pró Circulação®lead
Study Sites (18)
Instituto de Ensino e Treinamento em Saúde Vascular da Bahia
Salvador, Estado de Bahia, Brazil
Angiodiagnóstico - Instituto de Doenças Venosas e Linfáticas de Goiânia/Go
Goiânia, Goiás, Brazil
Clínica Médica Longevittá
Cuiabá, Mount, Brazil
Instituto de Cirurgia Vascular e Angiologia de Cascavel/PR
Cascavel, Paraná, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital Santa Casa de Curitiba
Curitiba, Paraná, Brazil
NICEP - Núcleo Integrado de Cirurgia Vascular e Pesquisa
Curitiba, Paraná, Brazil
Sociedade Evangélica Beneficente de Curitiba
Curitiba, Paraná, Brazil
Flebocurso
Londrina, Paraná, Brazil
Hospital dos Servidores do Estado do Pernambuco
Recife, Pernambuco, Brazil
Angio Vascular Hospital LTDA
Natal, Rio Grande do Norte, Brazil
Centro: Serviço de Cirurgia Vascular HSLPUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Clínica vascular MDC Sociedade Simples ME
Porto Alegre, Rio Grande do Sul, Brazil
Pró Saúde Clínica Médica
Tubarão, Santa Catarina, Brazil
Pró Circulação® - Clinic of Angiology and Vascular Surgery
Xanxerê, Santa Catarina, Brazil
Clínica Dr. Alexandre Reis EIRELI
Santos, São Paulo, Brazil
CIP - Fundação Faculdade de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
SAMAR Serviços Médicos
São Paulo, São Paulo, Brazil
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Matta, MD
Pró Circulação®
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 11, 2017
Study Start
May 1, 2018
Primary Completion
November 30, 2023
Study Completion
November 30, 2025
Last Updated
September 28, 2022
Record last verified: 2021-09