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Prospective Evaluation of the QoL of Patients With PTS Who Receive Compression Therapy and Sulodexide (SQUARES)

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ClinicalTrials.gov Identifier: NCT02512601
Recruitment Status : Terminated (Poor inclusion)
First Posted : July 31, 2015
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Bama GeVe, S.L.U.

Brief Summary:

This study aims to evaluate whether, in a standardised cohort of patients with mild to moderate PTS, monitored for a sufficiently long follow-up period, quality of life measured by generic instruments and disease-specific instruments evolves favourably in this patient profile.

Study objective: to evaluate the evolution of quality of life in general and in the specific context of the disease of patients who have experienced an episode of deep-vein thrombosis (DVT), are affected by post-thrombotic syndrome, are subject to compression therapy and receive an additional standard venoactive agent (sulodexide 15 mg twice daily during 6 months).


Condition or disease Intervention/treatment Phase
Post-thrombotic Syndrome Drug: Sulodexide Other: Compression therapy Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Evaluation of the Quality of Life of Patients With Post-thrombotic Syndrome Who Receive Compression Therapy and Sulodexide — SQUARES Study
Actual Study Start Date : September 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Sulodexide
Compression therapy + Sulodexide (two capsules of Sulodexide 15 mg twice daily).
Drug: Sulodexide
Sulodexide (two capsules of Sulodexide 15 mg twice daily).
Other Name: Aterina

Other: Compression therapy

Compression:

  • With an orthosis: Compression 22-29 mmHg, length of 20 cm above the DVT area.
  • With a bandage: 7-10 m long and 10 cm wide.
  • Both strategies (orthosis vs bandage) are equally applicable.




Primary Outcome Measures :
  1. Evaluation of the evolution (change at end of study visit from Baseline ) in the quality of life (QoL). [ Time Frame: Participants will be followed for the duration of their study participation, an expected average of 7 months. Change at end of study visit from baseline. ]

    QOL will be measured using both, the VEINES-QOL and SF-36 questionnaires.

    The total score of the quality-of-life questionnaires will be analysed and the changes that are observed during the study will be expressed as a mean (or median if necessary) with a 95% confidence interval (in the case of the median, using the bootstrapping procedure) and will be analysed to determine the probability of change against the null hypothesis (0 or no change) using a 95% confidence interval for the mean (or the median) and analysis of variance (if the distribution is normal) taking into account the presence of confounding factors.

    Questionnaires will be completed at each study visit:

    V1 "screening" V2 "inclusion" (1 month after screening) V3 (1 month after inclusion) V4 (3 months after inclusion) V5 (6 months after inclusion).



Secondary Outcome Measures :
  1. Size of the changes in the axes of the QoL questionnaires. [ Time Frame: Participants will be followed for the duration of their study participation, an expected average of 7 months. ]

    QOL will be measured using both, the VEINES-QOL and SF-36 questionnaires.

    The individual axes of the quality-of-life questionnaires will be analysed in the same way as the total score.

    Questionnaires will be completed at each study visit:

    V1 "screening" V2 "inclusion" (1 month after screening) V3 (1 month after inclusion) V4 (3 months after inclusion) V5 (6 months after inclusion).


  2. Assessment of the degree of correlation between the two QoL questionnaires. [ Time Frame: Participants will be followed for the duration of their study participation, an expected average of 7 months. ]

    QOL will be measured using both, the VEINES-QOL and SF-36 questionnaires.

    The correlation between the total scores on the two questionnaires, if applicable, will be analysed at all times by the Pearson correlation coefficient if both have a normal distribution; otherwise, Spearman's correlation analysis will be used.

    Questionnaires will be completed at each study visit:

    V1 "screening" V2 "inclusion" (1 month after screening) V3 (1 month after inclusion) V4 (3 months after inclusion) V5 (6 months after inclusion).


  3. Extent of the changes and evolution over time of the symptoms/signs evaluated with the VCSS scale (Venous Clinical Severity Score). [ Time Frame: Participants will be followed for the duration of their study participation, an expected average of 7 months. ]

    The changes on the VCSS scale will be reported and analysed in the same way as the primary endpoint

    Questionnaires will be completed at each study visit:

    V1 "screening" V2 "inclusion" (1 month after screening) V3 (1 month after inclusion) V4 (3 months after inclusion) V5 (6 months after inclusion).


  4. Number and percentage by organ and system of Adverse Event. [ Time Frame: Participants will be followed for the duration of their study participation, an expected average of 7 months. ]
    Adverse events will be tabulated and recorded by number and percentage by organ and system. Furthermore, the number of patients with at least one AE, with at least one AE potentially related to the treatment (therefore excluding only those events undoubtedly not related to the treatment), with at least one AE requiring treatment suspension and with at least one serious AE will be tabulated by number and percentage.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥ 18 years, ≤ 75 years, of both genders and any ethnic group.
  • Prior DVT documented by duplex colour Doppler ultrasound of the lower limbs (if the value of the D dimer and Doppler ultrasound are available, keep them as clinical documentation and note this in the CRF).The previous medical report that documented the prior DVT must be stored in the medical records.
  • Post-thrombotic syndrome (PTS) confirmed by duplex colour Doppler ultrasound of the lower limbs.2
  • Villalta score ≥ 5. To confirm the presence of PTS at V1, the patient must have a Villalta score ≥ 5 and a positive duplex colour Doppler ultrasound scan of the lower limbs.
  • Patients who use compression therapy in accordance with the study requirements. If the patient does not use compression therapy, it must be prescribed at the screening visit (V1) and continued throughout the patient's participation in the study.

During the study, compression therapy must be followed, and compliance will be recorded by the investigator. All patients must have the same degree of compression:

With an orthosis: Compression 22-29 mmHg, length of 20 cm above the DVT area. With a bandage: 7-10 m long and 10 cm wide. Both strategies (orthosis vs bandage) are equally applicable.

  • Patients of CEAP class: C0s - C5.
  • DVT occurred at least 6 months ago and no more than 5 years ago.
  • VEINES-QOL score ≤ 45 at the enrolment visit (V2). For definitive enrolment in the study at the enrolment visit (V2), the patient must have a total score on the VEINES-QOL questionnaire of:

    • Score ≤ 60 adding together the responses to the questions: 1.1-1.9; 4a-4d; 5a-5d; 8a-8e and at the same time
    • Score≥9 adding together the responses: 3; 6; 7 which, after standardisation of the questionnaire responses, must add up to a total VEINES-QOL score ≤ 45.
  • Patients with BMI ≤ 40.
  • Ability to complete the quality-of-life (QoL) questionnaire.
  • Patients able to use the study drug properly.
  • Ability to grant informed consent.
  • Women of child-bearing age must show a negative result on the urine pregnancy test and use a suitable contraceptive method (not including hormonal contraceptives) throughout the entire period of the study.
  • Any possible concomitant treatment with haemorheological, phlebostatic or other venoactive medications must be suspended at the screening visit.

Exclusion Criteria:

  • Patients < 18 years or > 75 years.
  • BMI > 40.
  • Ankle brachial index (ABI) < 0.75.
  • Primary chronic venous insufficiency.
  • Patients with known diagnosis of thrombophilia.
  • Unavailability of the medical report that documents the prior DVT.
  • Post-thrombotic syndrome not confirmed by duplex colour Doppler ultrasound of the lower limbs.
  • Solid malignant neoplasm or malignant blood disease in an active state or requiring chemotherapy/radiotherapy.
  • Inability to grant consent or refusal to do so.
  • Participation in another clinical study in the 4 months prior to screening or during this study.
  • Patients who do not comply with the compression therapy required by the protocol 3 (Detailed note after the inclusion criteria).
  • Patients with history of hypersensitivity to sulodexide or to any of the excipients of the investigational product.
  • Diagnosis of inflammatory joint disease or advanced collagen diseases.
  • Pregnancy, breast-feeding or desire to become pregnant during the study.
  • Concomitant treatment with anticoagulants, corticosteroids or immunosuppressants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512601


Locations
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Spain
Hospital de Cabueñes
Gijón, Asturias, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Baleares, Spain
Hospital Espirit Sant de Santa Coloma
Santa Coloma de Gramanet, Barcelona, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, Castilla la Mancha, Spain
Hospital Delfos
Barcelona, Cataluña, Spain
Hospital Universitario de Bellvitge
Barcelona, Cataluña, Spain
Hospital de Mataró
Mataró (Barcelona), Cataluña, Spain
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Cataluña, Spain
Hospital Universitario HM Montepríncipe
Boadilla del Monte, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarra, Spain
Hospital General de Castellón
Castellón, Valencia, Spain
Hospital Clínica Platón
Barcelona, Spain
Hospital Central de la Cruz Roja San José y Santa Adela
Madrid, Spain
Hospital Universitario La Princesa
Madrid, Spain
Hospital de Molina
Murcia, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Sponsors and Collaborators
Bama GeVe, S.L.U.
Investigators
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Study Chair: Josep Marinel.lo Hospital de Mataró, Consorci Sanitari del Maresme
Principal Investigator: Jesús Alós Hospital de Mataró, Consorci Sanitari del Maresme

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Responsible Party: Bama GeVe, S.L.U.
ClinicalTrials.gov Identifier: NCT02512601     History of Changes
Other Study ID Numbers: SULODEXIDE_PTS/01/13
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Postthrombotic Syndrome
Postphlebitic Syndrome
Syndrome
Disease
Pathologic Processes
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs