Chronic Venous Insufficiency Clinical Trial
— EVELINEOfficial title:
A Comparative Study to Assess the Efficacy and Safety of Endolex Forte vs Diosmin and Hesperidin in Reducing the symptomatoLogy of Patients With ChronIc VeNous Insufficiency Between Functional Classes CEAP 1-4, During a Period of 6 Months
The trial is designed as a randomized, multicenter, open label, comparative, 6 months, clinical study.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | June 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients, male or females aged 18 to 75 years old - BMI=40 - Presence of chronic venous insufficiency which is rated between functional classes CEAP 1-4 - Patients diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.or patients presenting a painful venous symptomatology in the lower limbs for at least 30 days. - Willing and able to give written informed consent prior to participation in the trial - Patients expected to be compliant with the study treatment Exclusion Criteria: - Known allergy to the product's ingredients - Pregnancy or breastfeeding - Patient is involved in any other clinical trial - Deep vein thrombosis - Stasis dermatitis - The patient is taking non-steroids anti-inflammatory drugs include oral , topical creams or patch form) - Open ulcers or lower extremity amputation - Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion - Patient presenting permanent oedema, - Patient with a history of lower limbs trauma responsible for sequel pains - NYHA III and IV Heart Failure - Renal Failure - Untreated or uncontrolled Arterial Hypertension - Hepatic Failure - History of a known liver disease such as hepatitis A, hepatitis B, or C. - Malignant neoplasms, from any etiology, or who are receiving any type of anticancer treatment, unless when properly treated and with no evidence of recurrence during the last five years - Previous history of alcoholism, drug abuse, psychological or emotional problems in the last 5 years that can invalidate the Informed Consent Form or restrain participant's ability to comply with the requirements of the protocol. - Immobility. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
SunWave Pharma | Opera Contract Research Organization SRL |
Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. Review. — View Citation
Monograph. Diosmin. Altern Med Rev. 2004 Sep;9(3):308-11. Review. — View Citation
Olin JW, Beusterien KM, Childs MB, Seavey C, McHugh L, Griffiths RI. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999;4(1):1-7. — View Citation
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. Review. — View Citation
Porter JM, Moneta GL. Reporting standards in venous disease: an update. International Consensus Committee on Chronic Venous Disease. J Vasc Surg. 1995 Apr;21(4):635-45. — View Citation
Rabe E, Stücker M, Ottillinger B. Water displacement leg volumetry in clinical studies--a discussion of error sources. BMC Med Res Methodol. 2010 Jan 13;10:5. doi: 10.1186/1471-2288-10-5. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in limb volume determination at day 180 (water displacement method) | 180 days | No | |
Secondary | Change from baseline in limb volume determination at day 90 (water displacement method) | 90 days | No | |
Secondary | Change from pre-treatment (baseline) in the calf circumference on treatment day 30 | 30 days | No | |
Secondary | Change from pre-treatment (baseline) in the calf circumference on treatment day 180 | 180 days | No | |
Secondary | Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 90 | 90 days | No | |
Secondary | Change from baseline in the subjective symptoms of CVI (tired, heavy legs, sensation of tension in the legs, pain in the legs) measured by Visual Analogue Scales (VAS) at day 180 | 180 days | No | |
Secondary | Global assessment of efficacy by the investigator at day 180 | 180 days | No | |
Secondary | Questionnaire on improvement in symptoms at day 180 (CIVIQ-20) | 180 days | No | |
Secondary | Global assessment of tolerability by the investigator at day 180 | 180 days | Yes | |
Secondary | Adverse events | 180 days | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02462096 -
A Feasibility Study of the ReLeaf Catheter System
|
N/A | |
Enrolling by invitation |
NCT05504070 -
Venclose digiRF System Post Market Study
|
N/A | |
Completed |
NCT05507346 -
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
|
N/A | |
Recruiting |
NCT05622500 -
Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease
|
N/A | |
Completed |
NCT03283800 -
Copper Impact on Venous Insufficiency and Lipodermatosclerosis
|
N/A | |
Completed |
NCT02236338 -
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein
|
Phase 4 | |
Terminated |
NCT02248740 -
Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein
|
Phase 4 | |
Completed |
NCT01501188 -
Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency
|
Phase 1 | |
Recruiting |
NCT05982405 -
Long-term Effects of Inspiratory Muscle Training in Chronic Venous Insufficiency
|
N/A | |
Completed |
NCT05383469 -
Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency
|
N/A | |
Completed |
NCT06238791 -
Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
|
||
Withdrawn |
NCT02559427 -
SPA Therapy in the Treatment of Sleep Apnea Syndrome
|
N/A | |
Completed |
NCT02346058 -
Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins
|
Phase 4 | |
Active, not recruiting |
NCT05926830 -
Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study
|
N/A | |
Withdrawn |
NCT05047302 -
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System-Canada
|
N/A | |
Active, not recruiting |
NCT04339075 -
Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
|
||
Active, not recruiting |
NCT04580160 -
Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System
|
N/A | |
Completed |
NCT02015221 -
Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
|
N/A | |
Completed |
NCT02050061 -
Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life
|
N/A | |
Completed |
NCT01432795 -
Practicability of Gliding Aids for Medical Compression Stockings
|
Phase 4 |