NCT05113420

Brief Summary

The aim of this study is to evaluate the efficacy and safety of different phlebotonic drugs in children and to assess patient satisfaction after treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 17, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2022

Completed
Last Updated

November 9, 2021

Status Verified

October 1, 2021

Enrollment Period

2.2 years

First QC Date

October 9, 2021

Last Update Submit

October 28, 2021

Conditions

Drug EffectChildren, OnlyVascular MalformationsSurgery

Outcome Measures

Primary Outcomes (1)

  • Coagulation testing

    Coagulation testing

    1 month

Other Outcomes (1)

  • Satisfaction after treatment

    1 month

Study Arms (4)

Per os+topical solution(1)

Drug: Detralex

Per os+topical solution(2)

Drug: DetralexDrug: Troxevasin

Per os only

Drug: Detralex

Topical solution only

Drug: DetralexDrug: Troxevasin

Interventions

DetralexDRUG

Diosmin+ Hesperidin

Per os onlyPer os+topical solution(1)Per os+topical solution(2)Topical solution only
TroxevasinDRUG

Troxerutin

Per os+topical solution(2)Topical solution only

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children

You may qualify if:

  • venous malformation

You may not qualify if:

  • allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Vascular Anomalies Center (VAC) "Hemangioma" LLC

Moscow, 109028, Russia

RECRUITING

MeSH Terms

Conditions

Vascular Malformations

Interventions

S 5682troxevasin

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ekaterina Listovskaia, MD

    Vascular Anomalies Center (VAC) "Hemangioma" LLC.

    STUDY CHAIR

  • Dmitriy Romanov, MD

    Vascular Anomalies Center (VAC) "Hemangioma" LLC.

    STUDY CHAIR

Central Study Contacts

Ekaterina Listovskaia

CONTACT

+79032069027listovskaya_ek@outlook.com

Study Design

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

Study Record Dates

First Submitted

October 9, 2021

First Posted

November 9, 2021

Study Start

September 17, 2019

Primary Completion

November 17, 2021

Study Completion

September 17, 2022

Last Updated

November 9, 2021

Record last verified: 2021-10

Locations

RU(1)