Comparing non-elastic compression garments to no compression for treating deep vein thrombosis
Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis: A Bayesian Adaptive Randomized Trial
This study is testing if wearing non-elastic compression garments can help people with deep vein thrombosis feel less pain and swelling, and prevent future complications, compared to not wearing any compression at all.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Pró Circulação® Academic / other |
| Locations | 18 sites (Bahia, BA and 17 other locations) |
| Trial ID | NCT03368313 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of non-elastic compression garments applied with high pressure against a control group receiving no compression in patients with acute deep vein thrombosis (DVT). The primary focus is on reducing pain and leg swelling during the acute phase of DVT and preventing postthrombotic syndrome (PTS) within six months of diagnosis. The trial hypothesizes that the use of non-elastic compression will lead to a quicker reduction in symptoms and a lower incidence of PTS compared to the control group. This approach is novel as previous studies have primarily focused on elastic compression stockings, which have shown limited effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are outpatients aged 18-80 with acute deep venous thrombosis of the lower extremity, experiencing symptoms for less than two weeks.
Not a fit: Patients with a history of thrombosis, severe arterial disease, or those requiring thrombus removal may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for reducing pain and preventing long-term complications in patients with deep vein thrombosis.
How similar studies have performed: While previous studies have explored non-elastic compression in other contexts, this specific approach for DVT has not been tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Bahia, BA and 17 other locations
- Instituto de Ensino e Treinamento em Saúde Vascular da Bahia — Bahia, Ba, Brazil (Recruiting)
- Angiodiagnóstico - Instituto de Doenças Venosas e Linfáticas de Goiânia/Go — Goiânia, Go, Brazil (Recruiting)
- Clínica Médica Longevittá — Cuiabá, Mount, Brazil (Recruiting)
- Hospital dos Servidores do Estado do Pernambuco — Recife, Pe, Brazil (Recruiting)
- Instituto de Cirurgia Vascular e Angiologia de Cascavel/PR — Cascavel, Pr, Brazil (Recruiting)
- Hospital Erasto Gaertner — Curitiba, Pr, Brazil (Recruiting)
- Hospital Santa Casa de Curitiba — Curitiba, Pr, Brazil (Recruiting)
- NICEP - Núcleo Integrado de Cirurgia Vascular e Pesquisa — Curitiba, Pr, Brazil (Recruiting)
- Sociedade Evangélica Beneficente de Curitiba — Curitiba, Pr, Brazil (Recruiting)
- Flebocurso — Londrina, Pr, Brazil (Recruiting)
- Angio Vascular Hospital LTDA — Natal, Rn, Brazil (Recruiting)
- Centro: Serviço de Cirurgia Vascular HSLPUCRS — Porto Alegre, Rs, Brazil (Recruiting)
- Clínica vascular MDC Sociedade Simples ME — Porto Alegre, Rs, Brazil (Recruiting)
- Pró Saúde Clínica Médica — Tubarão, Sc, Brazil (Recruiting)
- Pró Circulação® - Clinic of Angiology and Vascular Surgery — Xanxerê, Sc, Brazil (Recruiting)
- Clínica Dr. Alexandre Reis EIRELI — Santos, Sp, Brazil (Recruiting)
- CIP - Fundação Faculdade de Medicina de São José do Rio Preto — São José Do Rio Preto, Sp, Brazil (Recruiting)
- SAMAR Serviços Médicos — São Paulo, Sp, Brazil (Recruiting)
Study contacts
- Principal investigator: Eduardo Matta, MD — Pró Circulação®
- Study coordinator: Eduardo Matta, MD
- Email: procirculacao@gmail.com
- Phone: 55 (49) 3433-9050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.