Study of Antiinflammatory Effects of Detralex (Daflon)

NCT01654016 | Completed Phase 4

• 1 other identifier: Detra-001-Ajd
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Venous Insufficiency

Keywords

varicose veins; inflammation

Outcome Measures

Primary Outcomes (1)

• 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

  14 months

Secondary Outcomes (1)

• Clinical effects of Detralex (Daflon)

  14 months

Study Arms (2)

Detralex

ACTIVE COMPARATOR

Detralex 500 mg twice daily for three month prior to surgery

Drug: Detralex

Not taking Detralex

NO INTERVENTION

Not taking Detralex for three months prior to surgery

Interventions

Detralex DRUG

Detralex 500 mg twice daily for three month prior to surgery

Also known as: Daflon

Detralex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Dubrava: lead
• Servier: collaborator

Study Sites (1)

University Hospital Dubrava

Zagreb, 10000, Croatia

Location

Related Publications (6)

• Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. doi: 10.1161/01.CIR.0000164199.72440.08. No abstract available.

  PMID: 15883226 BACKGROUND

• Nicolaides AN. From symptoms to leg edema: efficacy of Daflon 500 mg. Angiology. 2003 Jul-Aug;54 Suppl 1:S33-44. doi: 10.1177/0003319703054001S05.

  PMID: 12934755 BACKGROUND

• Sezer A, Usta U, Kocak Z, Yagci MA. The effect of a flavonoid fractions diosmin + hesperidin on radiation-induced acute proctitis in a rat model. J Cancer Res Ther. 2011 Apr-Jun;7(2):152-6. doi: 10.4103/0973-1482.82927.

  PMID: 21768702 BACKGROUND

• Perrin M, Ramelet AA. Pharmacological treatment of primary chronic venous disease: rationale, results and unanswered questions. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):117-25. doi: 10.1016/j.ejvs.2010.09.025. Epub 2010 Dec 3.

  PMID: 21126890 BACKGROUND

• Bergan JJ. Chronic venous insufficiency and the therapeutic effects of Daflon 500 mg. Angiology. 2005 Sep-Oct;56 Suppl 1:S21-4. doi: 10.1177/00033197050560i104.

  PMID: 16193222 BACKGROUND

• Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD003229. doi: 10.1002/14651858.CD003229.pub4.

  PMID: 33141449 DERIVED

MeSH Terms

Conditions

Varicose Veins; Inflammation

Interventions

S 5682; Diosmin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Marko Ajduk, PhD

  University Hospital Dubrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 31, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2019
• Study Completion: September 1, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

CR (1)