NCT04138576

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
381

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 25, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

September 1, 2023

Completed
Last Updated

September 1, 2023

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 16, 2019

Results QC Date

August 20, 2021

Last Update Submit

October 21, 2022

Conditions

Chronic Venous Diseases

Outcome Measures

Primary Outcomes (1)

  • The Mean Subcutaneous Adipose Tissue Thickness Changes (mm) Between the Visit 3 and Baseline by Ultrasound Examination.

    Ultrasound examination was used to get: 1. Thickness of the thickness of the skin-fat fold at the affected skin area; 2. Presence of reflux or occlusion (with an indication of the terrotiry). * Measurements should be taken in the afternoon at about the same time, at visits V0 and V3. * The data are recorded only for the limb with the most severe changes. * Measurements are taken at the site of skin changes. Unit of Measure - mm

    6 months

Secondary Outcomes (12)

  • The Mean Changes VCSS for Pain (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale

    6 months

  • The Mean Changes VCSS for Hyperpigmentation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale

    6 months

  • The Mean Changes VCSS for Inflammation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale

    6 months

  • Outcome Measure Title: The Mean Changes VCSS for Subcutaneous Tissue Induration (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale

    6 months

  • The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). -Skin Tightening

    6 months

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic venous diseases of CEAP class C4a and C4b

You may qualify if:

  • Age 18 years old or above
  • Written informed consent
  • Diagnosis of chronic venous disease of CEAP class C4
  • No surgical intervention for CVD is planned by a doctor

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Medical and Surgical Center. N.I. Pirogov

Moscow, 105203, Russia

Location

Related Publications (1)

  • Bogachev V, Boldin B, Turkin P, Samenkov A, Dzhenina O. Micronized purified flavonoid fraction-based conservative treatment of chronic venous disease in a real-world setting. Future Cardiol. 2022 Sep;18(10):777-785. doi: 10.2217/fca-2022-0026. Epub 2022 Aug 25.

    PMID: 36004765DERIVED

Related Links

Results Point of Contact

Title
Medical Manager-Olga Linnik
Organization
ServierRussia
olga.linnik@servier.com
8-495-93707-00

Study Officials

  • Olga Linnik

    Medical manager

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 24, 2019

Study Start

December 25, 2019

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

September 1, 2023

Results First Posted

September 1, 2023

Record last verified: 2022-10

Locations

RU(1)