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

NCT02512601 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-08-31

No results posted yet for this study

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

Interventions

DRUG

Sulodexide

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

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.

Sponsors & Collaborators

  • Bama GeVe, S.L.U.

    lead INDUSTRY

Principal Investigators

  • Josep Marinel.lo · Hospital de Mataró, Consorci Sanitari del Maresme

  • Jesús Alós · Hospital de Mataró, Consorci Sanitari del Maresme

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02512601 on ClinicalTrials.gov