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

NCT02512601 | Terminated Phase 4

• 1 other identifier: SULODEXIDE_PTS/01/13
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 17

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).

Conditions

Post-thrombotic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Size of the changes in the axes of the QoL questionnaires.

  Participants will be followed for the duration of their study participation, an expected average of 7 months.

• Assessment of the degree of correlation between the two QoL questionnaires.

  Participants will be followed for the duration of their study participation, an expected average of 7 months.

• Extent of the changes and evolution over time of the symptoms/signs evaluated with the VCSS scale (Venous Clinical Severity Score).

  Participants will be followed for the duration of their study participation, an expected average of 7 months.

• Number and percentage by organ and system of Adverse Event.

  Participants will be followed for the duration of their study participation, an expected average of 7 months.

Study Arms (1)

Sulodexide

EXPERIMENTAL

Compression therapy + Sulodexide (two capsules of Sulodexide 15 mg twice daily).

Drug: Sulodexide; Other: Compression therapy

Interventions

Sulodexide DRUG

Sulodexide (two capsules of Sulodexide 15 mg twice daily).

Also known as: Aterina

Sulodexide

Compression therapy OTHER

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.

Sulodexide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Bama GeVe, S.L.U.: lead

Study Sites (17)

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, Spain

Location

Hospital Espirit Sant de Santa Coloma

Santa Coloma de Gramanet, Barcelona, Spain

Location

Complejo Hospitalario Universitario de Albacete

Albacete, Castille-La Mancha, Spain

Location

Hospital Delfos

Barcelona, Catalonia, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, Catalonia, Spain

Location

Hospital de Mataró

Mataró (Barcelona), Catalonia, Spain

Location

Hospital Universitari de Tarragona Joan XXIII

Tarragona, Catalonia, Spain

Location

Hospital Universitario HM Montepríncipe

Boadilla del Monte, Madrid, Spain

Location

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Location

Hospital de Cabueñes

Gijón, Principality of Asturias, Spain

Location

Hospital General de Castellón

Castellon, Valencia, Spain

Location

Hospital Clínica Platón

Barcelona, Spain

Location

Hospital Central de la Cruz Roja San José y Santa Adela

Madrid, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Hospital de Molina

Murcia, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Location

MeSH Terms

Conditions

Postthrombotic Syndrome

Interventions

glucuronyl glucosamine glycan sulfate

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Study Officials

• Josep Marinel.lo

  Hospital de Mataró, Consorci Sanitari del Maresme

  STUDY CHAIR

• Jesús Alós

  Hospital de Mataró, Consorci Sanitari del Maresme

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 31, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

ES (17)