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