A Phase 4 interventional study of Detralex in Chronic Venous Insufficiency, sponsored by University Hospital Dubrava. Completed at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by University Hospital Dubrava · Phase 4, Interventional, and Basic science
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).
Chronic venous disease (CVD) represents one of the most common vascular disorder. It's different clinical manifestations (most often seen as varicose veins) can be observed in up to 40% of adult female population and in about 30% of adult males.
Different mechanical and biological factors play role in the process of deterioration of venous wall tone and consequent vein valve disfunction that eventually lead to increase venous pressure . Evidence suggest that inflammation has a central place in this process even from the early stage of CVD.
Usual symptoms of venous insufficiency are pain, leg heaviness, night cramping, itching, and are often accompanied with leg edema. The extent of clinical manifestation may not correlate with patients' symptoms. Treatment of varicose veins encompasses vein surgery (stripping, phlebectomy, radiofrequency and laser ablation), sclerotherapy and compression therapy. Detralex (in some countries registered as Daflon) is an oral flavonoid that consists of 90% micronized diosmin and 10% flavonoids expressed as hesperidin. Several studies showed some beneficial effects of Detralex in alleviating symptoms in patients with CVD. It may be used in conjunction with surgery, sclerotherapy, or compression therapy or it may be the only therapy when other therapeutical modalities are not indicated or not feasable.
Animal studies showed antiinflammatory effects of Daflon in way that Daflon acts favorably on microcirculatory complications by normalizing the synthesis of prostaglandins and free radicals. It decreases bradykinin-induced microvascular leakage and inhibits leukocyte activation, trapping, and migration.
However, by searching the available literature (MEDLINE) we found no study that investigated what are the antiinflammatory effects of flavonoids in humans.
The aim of this study is to investigate if there is a differences in expression of inflammatory markers in venous wall and blood between patients treated with Detralex and those not treated with Detralex (control group).
189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.
This study's enrollment of 84 is above the median of 60 across 139 interventional studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →University Hospital Dubrava is the lead sponsor of 39 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Detralex 500 mg twice daily for three month prior to surgery
Drug: Detralex
Not taking Detralex for three months prior to surgery
Detralex 500 mg twice daily for three month prior to surgery
Also known as: Daflon
Antiinflammatory Effects of Detralex (Daflon)
The following markers of inflammation will be analyzed: Blood (biochemical analysis): soluble ICAM-1, soluble VCAM-1, E-selectin, L selectin PAI-1, TIMP-1, Angiopoietin-1, Angiopoietin-2 and Tie-2. Vein wall (\[immuno\]histological and biochemical analysis) : CD 45 (leukocytes), S100 (C-fibers), MMP3, MMP9, SMC (smooth muscle cells). Presence (or not) of microthrombi in the vein lumen
Time frame: 14 months
Clinical effects of Detralex (Daflon)
Subjective perception of pain, leg heaviness, cramping and itching will be assessed using visual analogue scale (VAS) graded from 0 to 10. Leg edema will be assessed by measuring the leg circumference. Data will be recorded as follow: 1. three months before the surgery 2. one day before the surgery 3. one week after the surgery 4. one month after bthe surgery 5. three months after the surgery
Time frame: 14 months
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University Hospital Dubrava