Post-thrombotic Syndrome Clinical Trial
— SQUARESOfficial title:
Prospective Evaluation of the Quality of Life of Patients With Post-thrombotic Syndrome Who Receive Compression Therapy and Sulodexide — SQUARES Study
Verified date | August 2017 |
Source | Bama GeVe, S.L.U. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 13 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario Universitario de Albacete | Albacete | Castilla la Mancha |
Spain | Hospital Clínica Platón | Barcelona | |
Spain | Hospital Delfos | Barcelona | Cataluña |
Spain | Hospital Universitario de Bellvitge | Barcelona | Cataluña |
Spain | Hospital Universitario HM Montepríncipe | Boadilla del Monte | Madrid |
Spain | Hospital General de Castellón | Castellón | Valencia |
Spain | Hospital Universitario de Getafe | Getafe | Madrid |
Spain | Hospital de Cabueñes | Gijón | Asturias |
Spain | Hospital Central de la Cruz Roja San José y Santa Adela | Madrid | |
Spain | Hospital Universitario La Princesa | Madrid | |
Spain | Hospital de Mataró | Mataró (Barcelona) | Cataluña |
Spain | Hospital de Molina | Murcia | |
Spain | Hospital Universitari Son Espases | Palma de Mallorca | Baleares |
Spain | Complejo Hospitalario de Navarra | Pamplona | Navarra |
Spain | Hospital Espirit Sant de Santa Coloma | Santa Coloma de Gramanet | Barcelona |
Spain | Hospital Universitari de Tarragona Joan XXIII | Tarragona | Cataluña |
Spain | Hospital Universitari i Politecnic La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Bama GeVe, S.L.U. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the evolution (change at end of study visit from Baseline ) in the quality of life (QoL). | 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). |
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. | |
Secondary | Size of the changes in the axes of the QoL questionnaires. | 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). |
Participants will be followed for the duration of their study participation, an expected average of 7 months. | |
Secondary | Assessment of the degree of correlation between the two QoL questionnaires. | 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). |
Participants will be followed for the duration of their study participation, an expected average of 7 months. | |
Secondary | Extent of the changes and evolution over time of the symptoms/signs evaluated with the VCSS scale (Venous Clinical Severity Score). | 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). |
Participants will be followed for the duration of their study participation, an expected average of 7 months. | |
Secondary | Number and percentage by organ and system of Adverse Event. | 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. | Participants will be followed for the duration of their study participation, an expected average of 7 months. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01432795 -
Practicability of Gliding Aids for Medical Compression Stockings
|
Phase 4 | |
Completed |
NCT01578122 -
Elastic Compression Stockings for Prevention of Post-thrombotic Syndrome
|
N/A | |
Withdrawn |
NCT01615692 -
The 36-month Extension to Follow up Sub Study
|
||
Recruiting |
NCT04833764 -
Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02767232 -
Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial
|
Phase 3 | |
Completed |
NCT02159521 -
Treatment of Chronic Deep Vein Thrombosis (DVT) and Post-Thrombotic Syndrome (PTS) With the EkoSonic® Endovascular System
|
Phase 4 | |
Recruiting |
NCT05701917 -
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
|
N/A | |
Completed |
NCT02433054 -
Bern Venous Stent Registry
|
||
Active, not recruiting |
NCT03833024 -
The MUFFIN-PTS Trial
|
Phase 3 | |
Completed |
NCT02942394 -
Treatment of the Postthrombotic Syndrome With the Oblique Stent - TOPOS Study
|
||
Completed |
NCT01846780 -
Treadmill Pilot Study (Invasive Pressure Measurements in PTS)
|
N/A | |
Active, not recruiting |
NCT03195777 -
Novel PET/CT and Treatment Strategies to Reduce PTS Following DVT
|
N/A |