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

• Status: Terminated
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bama GeVe, S.L.U.
• Treatments: Glucuronyl glucosamine glycan sulfate

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.