Clinical Trial: Prospective Evaluation of the QoL of Patients With PTS Who Receive Compression Therapy and Sulodexide

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective Evaluation of the Quality of Life of Patients With Post-thrombotic Syndrome Who Receive Compression Therapy and Sulodexide — SQUARES Study

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).

Detailed Summary:

Chronic venous insufficiency, or chronic venous disease (CVD), after prior deep-vein thrombosis (DVT), is diagnosed as post-thrombotic syndrome (PTS). It has been calculated that PTS occurs in between 20% and 50% of patients after an episode of DVT, even after having received optimal anticoagulant treatment, and this disorder usually consolidates in the first 2 years after the acute thrombotic episode. The presentation of PTS varies from mild symptoms or clinical signs to severe presentations in approximately 10% of cases, including chronic pain in the limbs that limits activity and ability to work, untreatable oedema and ulcers in the legs.

The cornerstone of the treatment of consolidated PTS is compression treatment, especially in the form of elastic compression stockings, and frequent elevation of the leg, despite the low level of evidence, but these measures require the strictest possible therapeutic compliance on the part of the patient. There is still little evidence that "venoactive" agents are effective in PTS symptoms; nevertheless, the use of medications in PTS is very widespread. In a study by González- Fajardo et al., the use of compression stockings is described in 75% of patients and, in a study by Lozano -Sánchez et al., their use is described in 62% of patients. In the latter study, venoactive drugs were used in approximately 90% of patients.

The diagnosis, staging, prognosis and evolution of the severity of the various entities grouped together under the heading of CVD, including PTS, are based mainly on scales and scoring systems. Objective evaluation of CVD severity tends to be based on the "clinical, etiologic, anatomic and pathophysiologic" (CEAP) clinical classification, the Venous Clinical Severity Score (VCSS) and the Villalta score. Nevertheless, at the present time it
Sponsor: Bama GeVe, S.L.U.

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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).

• 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).

• 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).

• 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.

Original Secondary Outcome: Same as current

Information By: Bama GeVe, S.L.U.

Dates:
Date Received: July 27, 2015
Date Started: September 2015
Date Completion: April 2017
Last Updated: November 18, 2015
Last Verified: November 2015