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Study of Antiinflammatory Effects of Detralex (Daflon)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01654016
First Posted: July 31, 2012
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Servier
Information provided by (Responsible Party):
Marko Ajduk, MD PhD, University Hospital Dubrava
July 24, 2012
July 31, 2012
May 16, 2017
August 2012
December 2017   (Final data collection date for primary outcome measure)
Antiinflammatory Effects of Detralex (Daflon) [ Time Frame: 14 months ]

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

Same as current
Complete list of historical versions of study NCT01654016 on ClinicalTrials.gov Archive Site
Clinical effects of Detralex (Daflon) [ Time Frame: 14 months ]

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
Same as current
Not Provided
Not Provided
 
Study of Antiinflammatory Effects of Detralex (Daflon)
Study of Antiinflammatory Effects of Detralex (Daflon) in Patients With Chronic Venous Disease

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).

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Chronic Venous Insufficiency
Drug: Detralex
Detralex 500 mg twice daily for three month prior to surgery
Other Name: Daflon
  • Active Comparator: Detralex
    Detralex 500 mg twice daily for three month prior to surgery
    Intervention: Drug: Detralex
  • No Intervention: Not taking Detralex
    Not taking Detralex for three months prior to surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
84
December 2017
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Croatia
 
 
NCT01654016
Detra-001-Ajd
No
Not Provided
Not Provided
Marko Ajduk, MD PhD, University Hospital Dubrava
University Hospital Dubrava
Servier
Principal Investigator: Marko Ajduk, PhD University Hospital Dubrava
University Hospital Dubrava
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP