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Evaluation of the Efficacy and Tolerability of Venoactive Drugs in Combination Therapy and Their Effect on the Overall Treatment Outcomes in Patients With Chronic Venous Diseases of CEAP Class C4a and C4b in Real Clinical Practice. (VAP-PRO-C4)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04138576
Recruitment Status : Not yet recruiting
First Posted : October 24, 2019
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Servier Russia

Brief Summary:
The study is aimed at evaluating the efficacy and tolerability of systemic pharmacotherapy as a part of combination treatment, and its influence on the overall treatment outcomes in patients with skin changes (CEAP class C4a and C4b).

Condition or disease
Chronic Venous Diseases

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of the Efficacy and Tolerability of Venoactive Drugs in Combination Therapy and Their Effect on the Overall Treatment Outcomes in Patients With Chronic Venous Diseases of CEAP Class C4a and C4b in Real Clinical Practice.
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2020



Primary Outcome Measures :
  1. Efficacy of systemic pharmacotherapy as part of combination therapy: change in the CEAP clinical class of CVD [ Time Frame: 3 month ]
    - change in the CEAP clinical class of CVD


Secondary Outcome Measures :
  1. Efficacy of systemic pharmacotherapy as part of combination therapy and its impact on the: area of affected skin determined by curvimetry technique (only in selected centers that use this technique routinely): skin density [ Time Frame: 3 month ]

    before and after the treatment in patients with skin changes of CEAP class C4a or C4b in real clinical practice

    - skin density determined by durometry technique (only in selected centers that use this technique routinely).


  2. Changes in the quality of life (global index score [GIS]) [ Time Frame: 3 month ]
    using the CIVIQ-14 questionnaire ( The resulting instrument comprised 14 items, split into three dimensions (pain, physical, and psychological), and was named CIVIQ-14) (SEE ATTACHMENT)

  3. Tolerability of systemic pharmacotherapy as part of combination therapy in patients with skin changes of CEAP class C4a or C4b: thickness of the skin-fat fold [ Time Frame: 3 month ]
    thickness of the skin-fat fold (ultrasound examination);

  4. Tolerability of systemic pharmacotherapy as part of combination therapy in patients with skin changes of CEAP class C4a or C4b: change in the CEAP clinical class of CVD [ Time Frame: 3 month ]
    change in the CEAP clinical class of CVD. (evolution of CVD symptoms characteristic for CEAP class C4 (sensations of skin tightening, burning, itching, pain, and exudation) using the Visual Analogue Scale (VAS))



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with chronic venous diseases of CEAP class C4a and C4b
Criteria

Inclusion Criteria:

  • Age 18 years old or above
  • Written informed consent
  • Patient did not receive treatment with venoactive drugs within the past 4 -weeks prior to the inclusion in the study
  • Diagnosis of chronic venous disease of CEAP class C4
  • No surgical intervention for CVD is planned by a doctor

Exclusion Criteria:

  • Chronic venous disease of СЕАР class C0-С3 or class С4-С6
  • History of alcohol or drug abuse or use of narcotic drugs
  • Peripheral artery disease
  • Lymphatic edema of the lower extremities
  • Secondary varicose veins, angiodysplasia, or neoplasia
  • Arterial disease (ankle-brachial index <0.9)
  • Infection within the past 6 weeks
  • Any of the following concomitant diseases, which can affect the results:
  • Connective tissue disease (including rheumatoid arthritis), arthritis
  • Heart failure
  • Chronic kidney disease
  • Decompensated diabetes mellitus
  • Skin diseases of non-venous origin
  • Intermittent claudication (peripheral artery disease)
  • Diseases of the bones or joints of the lower extremities
  • Malignancy

Treatment with drugs potentially causing leg edema (calcium channel blockers, hormonal drugs, NSAIDs, etc.) History of deep vein thrombosis (within the past year) History of superficial thrombophlebitis (within the past 3 months) History of surgical intervention (within the past 3 months) Patient cannot walk (regardless of the cause) Predictable poor adherence to treatment Participation of a patient in the intervention study within the previous 3 months For women: pregnancy or breastfeeding, the desire to become pregnant within at least 2 months after the study Patients with a contraindication to diosmin-containing agents, including Detralex Patient uses the topical treatments contraindicated in case of skin integrity violation.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138576


Locations
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Russian Federation
National Medical and Surgical Center. N.I. Pirogov
Moscow, Russian Federation, 105203
Contact: Stoyko Yuriy, prof    +7 985 784 88 60    ystoyko@mail.ru   
Sponsors and Collaborators
Servier Russia

Additional Information:
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Responsible Party: Servier Russia
ClinicalTrials.gov Identifier: NCT04138576    
Other Study ID Numbers: IC4-05682-059-RUS
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No