Treatment of Venous Malformation
1 other identifier
interventional
20
1 country
1
Brief Summary
Vascular malformations are birth defects that happen when different stages of angiogenesis shut down. 44 - 64% of all vascular malformations are venous malformations (VMs). Sclerotherapy is the first treatment line for VMs. It acts by getting rid of the vascular endothelial cells in the lesion. One of the most common and well researched sclerosing agents for VMs is polidocanol, which is a popular counterpart for concentrated ethanol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 1, 2022
CompletedFirst Posted
Study publicly available on registry
October 19, 2022
CompletedOctober 19, 2022
October 1, 2022
2.3 years
October 1, 2022
October 16, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Heaviness questionnaire
Heaviness of the affected part may be unchanged, or decreased or disppeared, or relapsed
6 months post operative
Disfigurement questionnaire
Disfigurementof the affected part may be unchanged, or decreased or disppeared, or relapsed
6 months post operative
size of venous malformation
it assess the size of malformations after injection; which may be unchanged, or decreased or disppeared, or relapsed
6 months post operative
Degree of satisfaction
It may be; Very satisfied, or satisfied, or not satisfied, or Dissatisfied.
6 months post operative
Study Arms (2)
Direct Puncture Repair / Ethanol
ACTIVE COMPARATORDirect Puncture Repair / Polidocanol
ACTIVE COMPARATORInterventions
Ethanol is an organic compound that will be injected in the venous malformation as a sclerotherapy by Direct Puncture Repair
Polidocanol is a sclerosing agent that will be injected in the venous malformation by Direct Puncture Repair
Eligibility Criteria
You may qualify if:
- Patients diagnosed with venous malformation of both genders and age above one year.
You may not qualify if:
- Age below one year.
- Patients had any other vascular malformations.
- Indication for contrast material or Alcohol and polidocanol injection.
- Unfit for general anesthesia. 5) Pregnancy. 6) Skin infection, inflammation, and ulcers.
- Pulmonary embolism.
- Acute Ischemia, and acute DVT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Walied Khereba
Zagazig, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 1, 2022
First Posted
October 19, 2022
Study Start
October 1, 2018
Primary Completion
January 1, 2021
Study Completion
March 1, 2021
Last Updated
October 19, 2022
Record last verified: 2022-10