Overview

Study of Antiinflammatory Effects of Detralex (Daflon)

Status:
Completed
Trial end date:
2019-09-01
Target enrollment:
0
Participant gender:
All
Summary
Aim of the study: To investigate if there is a differences in expression of inflammatory markers in venous wall and blood among patients treated with Detralex and those not treated with Detralex (control group).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital Dubrava
Collaborator:
Servier
Treatments:
Anti-Inflammatory Agents
Criteria
Inclusion Criteria:

- Chronic venous disease (CEAP 2 and 3) and saphenofemoral insufficiency

Exclusion Criteria:

- Previous deep venous thrombosis

- Previous or acute thrombophlebitis of the GSV (confirmed by duplex findings -
morphologic changes of the GSV above the knee)

- Immunological disorders

- Diabetes type I or II,

- Severe inflammatory disease: such as Behcet, lupus, Horton and other arteritis,
polyarthritis, spondylarthritis or sclerodermia

- Recent (less than 3 months) or scheduled non-authorized non-pharmacological
treatments:

- Sclerotherapy,

- Surgical treatment of varicose veins (crossectomy, phlebectomy),

- Endovenous treatment (endovenous laser, radiofrequency),

- Non-authorized pharmacological treatment in the last 3 months and during the study:

- Anti-inflammatory agents (except acetylsalicylic acid at dose 350 mg daily),

- Systemic corticosteroids or immunosuppressives,

- Venoactive drugs including open label MPFF,

- Pentoxifylline

- Patients already (at the time of randomization) taking Detralex for symptoms linked to
chronic venous disease

- Arterial insufficiency (absent pedal pulses or ABI < 0.9)

- Any important clinical or laboratory abnormalities

- Pregnancy, breastfeeding or wish of becoming pregnant during the study