Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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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

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Deep Vein Thrombosis Post Thrombotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Compression arm

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).

Group Type EXPERIMENTAL

Circaid

Intervention Type DEVICE

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).

Control arm

No compression

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Circaid

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).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No