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

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.

Study Overview

• Status: Recruiting
• Conditions: Deep Vein Thrombosis; Post Thrombotic Syndrome
• Intervention / Treatment: Device: Circaid

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduardo Matta, MD; Phone Number: 55 (49) 3433-9050; Email: procirculacao@gmail.com
• Study Contact Backup: Name: Clodoaldo A De Sá, Ph.D.; Phone Number: 55 (49) 3321-8215

Study Locations

• Brazil
  • BA
    • Bahia, BA, Brazil
      • Recruiting
      • Instituto de Ensino e Treinamento em Saúde Vascular da Bahia
      • Contact: Ronald Fidelis
  • GO
    • Goiânia, GO, Brazil
      • Recruiting
      • Angiodiagnóstico - Instituto de Doenças Venosas e Linfáticas de Goiânia/Go
      • Contact: Fabricio Santiago
  • Mount
    • Cuiabá, Mount, Brazil
      • Recruiting
      • Clínica Médica Longevittá
      • Contact: Alex Dornelles
  • PE
    • Recife, PE, Brazil
      • Recruiting
      • Hospital dos Servidores do Estado do Pernambuco
      • Contact: Carlos Eduardo Cunha
  • PR
    • Cascavel, PR, Brazil
      • Recruiting
      • Instituto de Cirurgia Vascular e Angiologia de Cascavel/PR
      • Contact: Jeferson Toregeani
    • Curitiba, PR, Brazil
      • Recruiting
      • Hospital Erasto Gaertner
      • Contact: Fabiano Luiz Erzinger
    • Curitiba, PR, Brazil
      • Recruiting
      • Hospital Santa Casa de Curitiba
      • Contact: Francisco Eduardo Coral
    • Curitiba, PR, Brazil
      • Recruiting
      • NICEP - Núcleo Integrado de Cirurgia Vascular e Pesquisa
      • Contact: Rosangela da Silva
    • Curitiba, PR, Brazil
      • Recruiting
      • Sociedade Evangélica Beneficente de Curitiba
      • Contact: Antonio Lacerda
    • Londrina, PR, Brazil
      • Recruiting
      • Flebocurso
      • Contact: Felipe Coelho
  • RN
    • Natal, RN, Brazil
      • Recruiting
      • Angio Vascular Hospital LTDA
      • Contact: Gutenberg do Amaral Gurgel
  • RS
    • Porto Alegre, RS, Brazil
      • Recruiting
      • Centro: Serviço de Cirurgia Vascular HSLPUCRS
      • Contact: Luciane Barreneche
    • Porto Alegre, RS, Brazil
      • Recruiting
      • Clínica vascular MDC Sociedade Simples ME
      • Contact: Luciano Amaral Domingues
  • SC
    • Tubarão, SC, Brazil
      • Recruiting
      • Pró Saúde Clínica Médica
      • Contact: Renan Candemil
    • Xanxerê, SC, Brazil
      • Recruiting
      • Pró Circulação® - Clinic of Angiology and Vascular Surgery
      • Contact: Eduardo Matta
  • SP
    • Santos, SP, Brazil
      • Recruiting
      • Clínica Dr. Alexandre Reis EIRELI
      • Contact: Alexandre Reis e Silva
    • São José Do Rio Preto, SP, Brazil
      • Recruiting
      • CIP - Fundação Faculdade de Medicina de São José do Rio Preto
      • Contact: Tiago Maschio
    • São Paulo, SP, Brazil
      • Recruiting
      • SAMAR Serviços Médicos
      • Contact: Marita Von Rautenfeld

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: 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).
No Intervention: Control arm; No compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline visit and at one, six and 12 months of followup visits.

Collaborators and Investigators

• Sponsor: Pró Circulação®
• Investigators: Principal Investigator: Eduardo Matta, MD, Pró Circulação®

Publications and helpful links

Helpful Links

• Circaid, a non-elastic compression garment

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2025

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Compression stockings; Nonelastic compression theraphy; Compression theraphy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: Circaid

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No